PAP system

ABSTRACT

A respiratory system is configured to pressurize and deliver a flow of respiratory gas to a patient&#39;s airways. The respiratory system includes a cushion configured to sealingly engage the patient&#39;s face and a blower mounted to the cushion and configured to pressurize a flow of respiratory gas. An interface structure is attached to an outlet of the blower and an aperture in the cushion. The interface structure forms a gas flow path between the cushion and the blower. The gas flow path is configured to deliver the pressurized respiratory gas from the blower through the aperture in the cushion. The gas flow path is also configured to vent exhaled gas from the aperture in the cushion to atmosphere. The respiratory system also includes headgear configured to support the cushion and the blower on the patient&#39;s face.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 14/804,515, filedJul. 21, 2015, now allowed, which is a continuation of U.S. Ser. No.13/393,187, filed Feb. 29, 2012, now issued as U.S. Pat. No. 9,132,252,which is the U.S. National Phase of International Application No.PCT/AU2010/001106, filed Aug. 27, 2010, which designed the U.S. andclaims the benefit of U.S. Provisional Applications 61/272,188, filedAug. 28, 2009, and 61/272,919, filed Nov. 19, 2009, and AustralianProvisional Applications AU2010900237, filed Jan. 22, 2010, 2010900304,filed Jan. 27, 2010, 2010900455, filed Feb. 5, 2010, and 2010900647,filed Feb. 18, 2010, the entire contents of each being incorporatedherein by reference in their entirety.

U.S. Provisional Applications 61/213,326, filed May 29, 2009,61/222,711, filed Jul. 2, 2009, 61/272,043, filed Aug. 11, 2009,61/272,162, filed Aug. 25, 2009, and 61/272,250, filed Sep. 4, 2009, areeach incorporated herein by reference in their entirety. InternationalApplication PCTAU2010/001031, filed Aug. 11, 2010, is incorporatedherein by reference in its entirety.

FIELD

The present technology relates to Positive Airway Pressure (PAP) systemsand/or methods of use for treatment, e.g., of Sleep Disordered Breathing(SDB) with Continuous Positive Airway Pressure (CPAP) or Non-InvasivePositive Pressure Ventilation (NIPPY).

BACKGROUND

Examples of head mounted blowers, wearable CPAP, or portable CPAP areknown in the art. For example, see U.S. Patent Application Publications2006/0237013 A1 and 2009/0320842 A1, each incorporated herein byreference, and the BreatheX™ system.

SUMMARY

Certain embodiments relate to minimalistic CPAP systems, methods of useand devices structured to at least reduce impact on the patient.

Certain embodiments relate to patient interfaces that incorporates arelatively small or miniature blower.

Certain embodiments relate to CPAP systems, methods of use and devicesstructured to at least reduce size and bulk, reduce vibrations, reducegenerated noise or combinations thereof.

Certain embodiments relate to small CPAP devices configured to supplypressurized breathable gas (e.g., air) in a manner suitable fortreatment of sleep apneas.

Certain embodiments relate to PAP systems including a patient interfaceincluding sealing arrangement adapted to form a seal with the patient'snose and/or mouth and headgear to support the sealing arrangement inposition on the patient's head. A blower is structured to generate asupply of pressurized air. The blower is supported by the patientinterface on the patient's head (e.g., within or formed as part of theheadgear or cushion (e.g., integrated with nozzles) and in communicationwith the patient interface. The headgear may form one or more ducts tocommunicate pressurized air from the blower to a breathing cavitydefined by the sealing arrangement. Alternatively, a separate tube maybe provided to communicate pressurized air from the blower to thesealing arrangement.

Certain embodiments relate to PAP devices including a portable blowerstructured to generate a supply of pressurized air and a blower dockSch1 structured to retain, charge, and/or download diagnostics from theblower.

Certain embodiments relate to PAP systems and methods of use thatinclude a patient interface, a portable blower structured to generate asupply of pressurized air, and a blower support structure structured tosupport the portable blower on the patient's body.

Certain embodiments relate to PAP systems and methods of use thatinclude a patient interface including sealing arrangement adapted toform a seal with the patient's nose and/or mouth and headgear to supportthe sealing arrangement in position on the patient's head, a blowerstructured to generate a supply of pressurized air, the blower supportedby the patient interface on the patient's head and in communication withthe patient interface, and a blower support structured to support theblower on the patient's head and dampen vibrations and/or noise from theblower in use. The blower support includes an inflatable cushionincluding an inflatable chamber adapted to be inflated by pressurizedair from the blower.

Certain embodiments relate to headgears including a plurality of straps,wherein one or more selected portions of the straps include a bladder orpocket. In certain embodiments, the one or more selected portions of thestraps include a bladder or pocket of vibration damping material todampen vibrations.

Certain embodiments relate to PAP systems and methods of use thatinclude a patient interface including sealing arrangement adapted toform a seal with the patient's nose and/or mouth and headgear to supportthe sealing arrangement in position on the patient's head, a blowerstructured to generate a supply of pressurized air, the blower supportedby the patient interface on the patient's head and in communication withthe patient interface, and a blower support structured to support theblower on the patient's head. The blower includes at least one inletoriented at angles between normal to parallel to the plane of thepatient's face. In certain embodiments, the blower includes at least oneinlet oriented at angles between substantially normal to substantiallyparallel to the plane of the patient's face.

Certain embodiments relate to PAP systems or methods of use that includea patient interface including sealing arrangement adapted to form a sealwith the patient's nose and/or mouth and headgear to support the sealingarrangement in position on the patient's head, a blower structured togenerate a supply of pressurized air, the blower supported by thepatient interface on the patient's head and in communication with thepatient interface, and a blower support structured to support the bloweron the patient's head. The blower includes at least one inlet which isattached to a snorkel arrangement.

Certain embodiments relate to PAP systems or methods of use that includea patient interface including sealing arrangement adapted to form a sealwith the patient's nose and/or mouth and headgear to support the sealingarrangement in position on the patient's head, a blower structured togenerate a supply of pressurized air, the blower supported by thepatient interface on the patient's head and in communication with thepatient interface, and a blower support structured to support the bloweron the patient's head. The blower includes at least dual inlets. Incertain embodiments, at least one of the inlets may be substantiallycylinder shaped.

Certain embodiments relate to PAP systems or methods of use that includea patient interface including sealing arrangement adapted to form a sealwith the patient's nose and/or mouth and headgear to support the sealingarrangement in position on the patient's head, a blower structured togenerate a supply of pressurized air, the blower supported by thepatient interface on the patient's head and in communication with thepatient interface, and a blower support structured to support the bloweron the patient's head. The blower may be decoupled, or substantiallydecoupled, from the headgear and/or the patient's head to reducevibration transmission. The blower may be decoupled, or substantiallydecoupled, with the housing by the use of shock and/or vibrationabsorbing housing mounts.

Certain embodiments relate to PAP systems or methods of use that includea patient interface including sealing arrangement adapted to form a sealwith the patient's nose and/or mouth and headgear to support the sealingarrangement in position on the patient's head, a blower structured togenerate a supply of pressurized air, the blower supported by thepatient interface on the patient's head and in communication with thepatient interface, and a blower support structured to support the bloweron the patient's head. In certain embodiments, the blower is at leastpartially encapsulated in a polymer, such as an elastic polymer (orother suitable material) which is mounted in a housing and the outersurface of the encapsulation includes at least one vibration absorbingprotrusion.

Certain embodiments relate to PAP systems or methods of use that includea patient interface including sealing arrangement adapted to form a sealwith the patient's nose and/or mouth and headgear to support the sealingarrangement in position on the patient's head, a blower structured togenerate a supply of pressurized air, the blower supported by thepatient interface on the patient's head and in communication with thepatient interface, and a blower support structured to support the bloweron the patient's head. The blower is mounted in a housing wherein themotor and electronics are mounted in the housing away or remote from thepatient's head, e.g., relative to other components of the blower.

Certain embodiments relate to PAP systems or methods of use that includea patient interface including sealing arrangement adapted to form a sealwith the patient's nose and/or mouth and headgear to support the sealingarrangement in position on the patient's head, a blower structured togenerate a supply of pressurized air, the blower supported by thepatient interface on the patient's head and in communication with thepatient interface, and a blower support structured to support the bloweron the patient's head. The blower is mounted in a housing and thehousing is substantially configured to match the surface of the crown orfront portion of a patient's head. In certain embodiments, the housinghas at least in part a rounded configuration.

Certain embodiments may include PAP devices or systems adapted to beworn or carried. The PAP systems may include a flow generator adapted tobe positioned on the crown of a patient's head using headgear. Incertain embodiments, the flow generator may be adapted to be mounted onthe front portion of a patient's head using headgear. The headgear mayinclude a combination of straps, rigidisers. EMF shielding orcombinations thereof. In certain embodiments the headgear is adapted tominimize or limit movement of the flow generator on the patient's headand also secure a patient interface to the patient's face. In certainembodiments the headgear is adapted to substantially minimize orsubstantially limit movement of the flow generator on the patient's headand also secure a patient interface to the patient's face.

In certain embodiments, the flow generator may also include features tominimize or isolate noise and vibration transmission, when in use. Thesefeatures may include: foam mounting of the blower within a housing ofthe flow generator, and/or inlets being directed away from the patient'sface and ears.

In certain embodiments, the flow generator may also include variousfeatures to improve comfort and/or fit of the device including a curvedlower surface.

In certain embodiments, the present technology may include a PAP deviceor system adapted to be worn or carried by a patient. The PAP system mayinclude a flow generator adapted to be mounted on the crown of apatient's head using headgear. In certain embodiments, the flowgenerator may be positioned on the front portion of a patient's headusing headgear. The headgear may include a combination of straps,rigidisers, EMF shielding or combinations thereof.

The headgear may be adapted to minimize or limit movement of the flowgenerator on the patient's head and also secure a patient interface tothe patient's face.

Certain embodiments provide a mask system that is simple and/orunobtrusive configuration. Certain embodiments provide mask systems thatcan accommodate a wide range of different facial shapes. Certainembodiments provide mask systems with a wide fit range.

Certain embodiments provide a cushion that is adapted to form a sealaround a nose of a patient including a seal in a nasal bridge region ofa patient. The nasal bridge region is a region of greater variabilitybetween different patients than other regions of a nose. Another regionof potential variability between faces is an angle of the forehead withrespect to a plane of the face.

In order to accommodate a wide range of face shapes, a series of masksof different sizes and shapes may be constructed. However this may beexpensive. In accordance with certain embodiments, a cushion angleadjustment mechanism for mask systems may be provided to facilitaterotation of the cushion with respect to the plane of the face. In thisway, a given mask system is able to accommodate a wider fit range ofpatients.

The cushion size and shape may be structured to accommodate a wide rangeof different facial shapes.

Certain embodiments relate to mask systems including a frame adapted toattach to headgear, a sealing arrangement releasably connectable to theframe, and an elbow provided to the sealing arrangement and adapted tobe connected to an air delivery tube that delivers breathable gas to thepatient. The sealing arrangement defines a breathing chamber and isadapted to form a seal with at least a portion of the patient's face.The sealing arrangement includes structure to establish a positiveconnection with the frame and with the elbow.

Certain embodiments relate to mask systems including a frame and asealing arrangement provided to the frame. The sealing arrangementincludes a silicone cushion and a foam cushion provided to the siliconecushion. The silicone cushion defines a breathing chamber and the foamcushion is supported by the silicone cushion such that the foam cushionis not in communication with the breathing chamber. The foam cushionsupports the sealing arrangement on the frame. In certain embodiments,the silicone cushion defines a breathing chamber and the foam cushion issupported by the silicone cushion such that the foam cushion issubstantially not in communication with the breathing chamber.

Certain embodiments relate to mask systems including a frame adapted toattach headgear and a sealing arrangement releasably connectable to theframe. The sealing arrangement defines a breathing chamber and isadapted to form a seal with the patient's face. The sealing arrangementincludes one or more protrusions adapted to interlock with respectiveopenings provided to the frame. In certain embodiments, the sealingarrangement includes one or more protrusions adapted to interlock withrespective openings provided to the frame and provide visualreinforcement that the connection has been established.

Certain embodiments relate to a sealing arrangement for mask systemsincluding a side wall defining a breathing chamber, an undercushioncurving outwards from the side wall and away from the breathing cavity,and a membrane that at least partially covers the undercushion. Themembrane extends from the undercushion and curves inwards into thebreathing cavity.

Certain embodiments relate to mask systems including a frame, a sealingarrangement releasably connectable to the frame, an elbow provided tothe sealing arrangement and adapted to be connected to an air deliverytube that delivers breathable gas to the patient, and a forehead supportprovided to the frame. The sealing arrangement defines a breathingchamber and is adapted to form a seal with the patient's face. Theforehead support includes an elongated arm adapted to extend from theframe and an upper headgear connector adapted to attach upper headgearstraps. In certain aspects, at least a portion of the arm is constructedfrom metal.

Certain embodiments may relates to mask systems including a frame, asealing arrangement releasably connectable to the frame, an inlet tubeprovided to the sealing arrangement and adapted to be connected to anair delivery tube that delivers breathable gas to the patient, and aforehead support provided to the frame. Where the sealing arrangementmay be integrally, or substantially integrally, joined to an inlet tubeextending in a vertically direction from the sealing arrangement, whenworn. The inlet tube may be releasably retained by frame. The sealingarrangement may include a vent.

In certain embodiments, the mask system may be adapted for use with atravel PAP device wherein the mask system is secured in place on apatient by headgear and headgear also secures a flow generatordelivering pressurized breathable gas to the mask system.

Other embodiments, aspects, features, and/or advantages of thistechnology will become apparent from the following detailed descriptionwhen taken in conjunction with the accompanying drawings, which are apart of this disclosure and which illustrate, by way of example,principles of e s disclosed technology. In certain embodiments, PAPsystems are disclosed that may be configured to provide a minimal visualfootprint in use. The flow generator of such PAP systems comprises atleast one blower and/or at least one blower housing and are in aircommunication with a patient interface. In addition, these PAP systemsmay include other structural elements (for example, but not limited, toheadgear, shoulder-type harnesses, pendant-type arrangements, articlesof clothing, straps or band arrangements or combinations thereof)resulting in PAP systems that may be portable, carried by the patient,used for travel, mask mounted, head mounted or combinations thereof.

In certain embodiments, the height of the flow generator may be, forexample, less than 100 mm, less than 80 mm, less than 60 mm, less than40 mm, or less than 20 mm. The volume of the flow generator may be, forexample, less than 400 cm³, less than 350 cm³, less than 300 cm³ lessthan 250 cm³, less than 200 cm³, less than 150 cm³, less than 125 cm³,less than 100 cm³, less than 75 cm³, or less than 50 cm³. The flowgenerator excluding the weight of batteries may weigh, for example, lessthan 500 g, less than 400 g, less than 300 g, less than 250 g, less than200 g, less than 150 g or less than 100 g. The noise output by the flowgenerator may be, for example, less than 70 dBA, less than 60 dBA, lessthan 50 dBA, less than 46 dBA, or less than 40 dBA, or less than 35 dBA.

In addition, certain embodiments of the flow generator may be configuredsuch that the flow generator may be positioned at a range of angles andpositions through the night as the patient rolls around in their sleepand still suitably function. Certain flow generators may suitablyfunction at multiple axes of orientation. In certain embodiments, atleast one blower may be a single stage axial blower.

In certain embodiments, the PAP system may include at least one dampingstructure to reduce the vibrations perceived by the user of the PAPsystem. In certain embodiments, the PAP system may comprise at least onedamping structure that reduces the vibration perceived by the user by atleast 20%, 30%, 40%, 50%, 60%, 70% or 80%. In certain embodiments, thePAP system may comprise at least two damping structures that reduce thevibration perceived by the user by at least 20%, 30%, 40%, 50%, 60%, 70%or 80%. In certain embodiments, the PAP system may comprise at leastthree damping structures that reduce the vibration perceived by the userby at least 20%, 30%, 40%, 50%, 60%, 70% or 80%. In certain embodiments,the PAP system may comprise at least one damping structure that reducesthe vibration perceived by the user from the flow generator by at least20%, 30%, 40%, 50%, 60%, 70% or 80%.

In certain embodiments, the PAP system may comprise at least two dampingstructures that reduce the vibration perceived by the user from the flowgenerator by at least 20%, 30%, 40%, 50%, 60%, 70% or 80%. In certainembodiments, the PAP system may comprise at least three dampingstructures that reduce the vibration perceived by the user from the flowgenerator by at least 20%, 30%, 40%, 50%, 60%, 70% or 80%. In certainembodiments, the vibration and/or noise output of the flow generator (indBA), the height of the flow generator (in mm), the volume of the flowgenerator (in cm3), the weight of the flow generator excluding batteries(in grams), may be combined in various combinations to provide PAPsystems with a minimal visual footprint in use and reduced noise and/orvibration output in use.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this technology. In such drawings:

FIGS. 1A to 1C show a headworn PAP system according to certainembodiments;

FIG. 2 shows a headworn PAP system according to certain embodiments;

FIGS. 3A to 3F show a headworn PAP system according to certainembodiments;

FIG. 4 shows a patient interface with a built-in blower according tocertain embodiments;

FIGS. 5A and 5B show a patient interface with a built-in bloweraccording to certain embodiments;

FIGS. 6A and 6B show a patient interface with a built-in bloweraccording to certain embodiments;

FIGS. 7A and 7B show a patient interface with a built-in bloweraccording to certain embodiments;

FIGS. 8A and 8B show a patient interface with a built-in bloweraccording to certain embodiments;

FIGS. 9A to 9C show a patient interface with a built-in blower accordingto certain embodiments;

FIG. 10 shows a portable blower according to certain embodiments;

FIG. 11 shows a portable blower according to certain embodiments;

FIG. 12 shows a headworn PAP system according to certain embodiments;

FIG. 13 shows a headworn PAP system according to certain embodiments;

FIG. 14 shows a headworn PAP system according to certain embodiments;

FIG. 15 shows a headworn PAP system according to certain embodiments;

FIGS. 16A to 16C show a headworn PAP system according to certainembodiments;

FIG. 17 shows a headworn PAP system according to certain embodiments;

FIG. 18 shows a headworn PAP system according to certain embodiments;

FIG. 19 shows a headworn PAP system according to certain embodiments;

FIG. 20 shows a headworn PAP system according to certain embodiments;

FIG. 21 shows a headworn PAP system according to certain embodiments;

FIG. 22 shows a headworn PAP system according to certain embodiments;

FIG. 23 shows a headworn PAP system according to certain embodiments;

FIG. 24 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 25 shows a patient interface with built-in blowers according tocertain embodiments;

FIG. 26 shows a patient interface: with a built-in blower according tocertain embodiments;

FIGS. 27A and 27B show a patient interface with a built-in bloweraccording to certain embodiments;

FIG. 28 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 29 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 30 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 31 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 32 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 33 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 34 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 35 shows a patient interface: with a built-in blower according tocertain embodiments;

FIG. 36 shows a portable blower according to certain embodiments;

FIGS. 37A and 37B show a portable blower according to certainembodiments;

FIGS. 38A to 38D show a portable blower according to certainembodiments;

FIG. 39 shows light-up tubing according to certain embodiments;

FIGS. 40A and 40B show a wearable blower according to certainembodiments;

FIGS. 41A and 41B show a wearable and/or portable blower according tocertain embodiments;

FIGS. 42A to 42C shows a wearable blower according to certainembodiments;

FIG. 43 shows a wearable blower according to certain embodiments;

FIG. 44 shows a wearable blower according to certain embodiments;

FIG. 45 shows a portable blower according to certain embodiments;

FIG. 46 shows a portable blower according to certain embodiments;

FIG. 47 shows a portable blower according to certain embodiments;

FIGS. 48 and 49 show a portable blower according to certain embodiments;

FIG. 50 shows a wearable blower according to certain embodiments;

FIG. 51 shows a wearable blower according to certain embodiments;

FIG. 52 shows a wearable blower according to certain embodiments;

FIGS. 53A and 53B show a front and top view, respectively, of a headwornPAP system according to certain embodiments;

FIGS. 54A and 54B show right front perspective and right side views,respectively, of the PAP system of FIGS. 53A and 53B;

FIGS. 55A and 55B show right rear perspective and left rear perspectiveviews, respectively, of the PAP system of FIGS. 53A to 54B;

FIGS. 56 and 57 show alternative views of a headworn PAP systemaccording to certain embodiments;

FIGS. 58 and 59 show alternative views of a headworn PAP systemaccording to certain embodiments;

FIGS. 60 and 61 show alternative views of a headworn PAP systemaccording to certain embodiments;

FIGS. 62 and 63 show alternative views of a headworn PAP systemaccording to certain embodiments;

FIGS. 64 and 65 show alternative views of a headworn PAP systemaccording to certain embodiments;

FIGS. 66 and 67 show alternative views of a headworn PAP systemaccording to certain embodiments;

FIG. 68A shows a blower support for a blower according to certainembodiments;

FIG. 68B is a cross-sectional view of the blower support of FIG. 68A;

FIG. 69 shows a blower support for a blower according to certainembodiments;

FIGS. 70, 71, and 72 are various views of a blower support for a bloweraccording to certain embodiments;

FIGS. 73 and 74 are various views of a blower support for a bloweraccording to certain embodiments;

FIG. 75 shows headgear according to certain embodiments;

FIGS. 76 and 77 show exemplary cross-sections through the headgear ofFIG. 75;

FIG. 78 shows a blower including a damping structure according tocertain embodiments;

FIG. 79 shows a blower including a damping structure according tocertain embodiments;

FIG. 80 shows a blower including a damping structure according tocertain embodiments;

FIGS. 81 and 82 show a blower including a damping structure according tocertain embodiments;

FIGS. 83 and 84 show a blower including a damping structure according tocertain embodiments;

FIG. 85 shows a blower including a damping structure according tocertain embodiments;

FIG. 86 is a cross-sectional view of a blower according to certainembodiments;

FIG. 87 is a perspective view of a lower portion of a blower housingaccording to certain embodiments;

FIG. 88 is a side view of the lower portion shown in FIG. 87;

FIG. 89 is a bottom view of the lower portion shown in FIG. 87;

FIG. 90 is a perspective view of the blower housing including the lowerportion of FIG. 87;

FIG. 91 is a side view of the blower housing shown in FIG. 90;

FIG. 92 is a perspective view of a blower housing according to certainembodiments;

FIG. 93 is a side view of the blower housing shown in FIG. 92;

FIG. 94 is a bottom view of the blower housing shown in FIG. 92;

FIG. 95 is a top view of the blower housing shown in FIG. 92;

FIG. 96 is a rear view of the blower housing shown in FIG. 92;

FIG. 97 is a front view of the blower housing shown in FIG. 92;

FIG. 98 is a top perspective view of the blower housing shown in FIG.92, wherein an upper portion of the housing has been removed to show thelower portion and the interior;

FIG. 99 is a top view of the lower portion shown in FIG. 98;

FIG. 100 is a perspective view of a blower housing according to certainembodiments;

FIG. 101 is a side view of the blower housing of FIG. 100;

FIG. 102 is a top view of the blower housing of FIG. 100;

FIG. 103 is a rear view of the blower housing of FIG. 100;

FIG. 104 is a front view of the blower housing of FIG. 100;

FIG. 105 is a perspective view of the blower housing shown in FIG. 100,wherein an upper portion of the housing has been removed to show thebottom portion and the interior;

FIG. 106 is a top view of the lower portion shown in FIG. 105;

FIG. 107 is a perspective view of a blower housing according to certainembodiments;

FIG. 108 is a top view of the blower housing of FIG. 107;

FIG. 109 is a side view of the blower housing of FIG. 107;

FIG. 110 is a rear view of the blower housing of FIG. 107;

FIG. 111 is a front view of the blower housing of FIG. 107;

FIG. 112 is a top view of the blower housing shown in FIG. 107, whereinan upper portion of the housing has been removed to show the bottomportion and the interior;

FIG. 113 is a perspective view of an enclosure for a blower or airgenerator according to certain embodiments;

FIG. 114 is a bottom view of FIG. 113;

FIG. 115 is a side view of FIG. 113;

FIG. 116 is an alternate side view of FIG. 113;

FIG. 117 is a top view of FIG. 113;

FIGS. 118-122 are alternative views of a blower within a blower housingaccording to certain embodiments;

FIGS. 123A to 129 show alternative examples of a blower housingincluding wings or outwardly flared portions according to certainembodiments.

FIG. 130 shows a perspective view of a portion of a headgear accordingto certain embodiments;

FIG. 131 shows a flattened top view of the headgear shown in FIG. 130;

FIG. 132 shows a cross-sectional view of the extension portion forming aportion of FIG. 130;

FIG. 133 shows a top view of a rigidiser forming a portion of FIG. 130;

FIG. 134 shows a top view of EMF shield forming a portion of FIG. 130;

FIG. 135 shows a top view of a strap forming a portion of FIG. 130;

FIG. 136 shows a cross-sectional view of the strap of FIG. 135;

FIG. 137 shows a top view of a flow generator forming part of FIG. 130;

FIG. 138 shows a side view the flow generator depicted in FIG. 137;

FIG. 139 shows a first cross-sectional view of the flow generator ofFIG. 138;

FIG. 140 shows a second cross-sectional view of the flow generator ofFIG. 138;

FIG. 141 shows a third cross-sectional view of the flow generator ofFIG. 138;

FIG. 142 shows a fourth cross-sectional view of the flow generator ofFIG. 138;

FIG. 143 shows a fifth cross-sectional view of the flow generator ofFIG. 138;

FIG. 144 shows a sixth cross-sectional view of the flow generator ofFIG. 138;

FIG. 145 shows a perspective view of certain embodiments of a flowgenerator;

FIG. 146 shows an exploded view of FIG. 145;

FIG. 147 shows a shows a first cross-sectional view of FIG. 145;

FIG. 148 shows a shows a second cross-sectional view of FIG. 145;

FIGS. 149 and 150 show perspective views of certain embodiments of aheadgear and flow generator arrangement;

FIG. 151 shows a rear view of FIGS. 149 and 150;

FIG. 152 shows a rear view of certain embodiments of a headgear and flowgenerator arrangement;

FIGS. 153 and 154 show perspective views of FIG. 152;

FIG. 155 shows a front view of a portion of FIG. 152.

FIG. 156 shows a perspective view of certain embodiments of a PAPsystem;

FIG. 157 shows a perspective view of certain embodiments of a PAPsystem;

FIG. 158 shows a cross-sectional view of a portion of FIG. 157;

FIG. 159 shows an exploded view of a portion FIG. 157;

FIG. 160 shows a schematic view of a diagram depicting power supplyarrangements for the embodiment of FIG. 157;

FIGS. 161 and 162 are perspective views of a sealing arrangement, orcushion assembly, according to certain embodiments;

FIG. 163 is a side view of the cushion assembly of FIG. 161;

FIG. 164 is a front view of the cushion assembly of FIG. 161;

FIG. 165 is a side view of the cushion assembly of FIG. 161;

FIG. 166 is a rear view of the cushion assembly of FIG. 161;

FIG. 167 is a bottom view of the cushion assembly of FIG. 161;

FIG. 168 is a top view of the cushion assembly of FIG. 161;

FIG. 169 is a perspective view of a frame of a patient interfaceaccording to certain embodiments;

FIG. 170 is a side view of the frame of FIG. 169;

FIG. 171 is a front view of the frame of FIG. 169;

FIG. 172 is a side view of the frame of FIG. 169;

FIG. 173 is a front view of the frame of FIG. 169;

FIG. 174 is a bottom view of the frame of FIG. 169;

FIG. 175 is an exploded front perspective view of a patient interface,or mask, system according to certain embodiments;

FIG. 176 is a back assembly view of FIG. 175;

FIG. 177 is a side assembly view of FIG. 175;

FIG. 178 is a front assembly view of FIG. 175;

FIG. 179 is an exploded back perspective view of FIG. 175;

FIG. 180 is a perspective view of tubing to adapted to connect to thecushion assembly of FIG. 161;

FIG. 181 is a front view of the tubing shown in FIG. 180;

FIG. 182 is a cross sectional view of FIG. 181;

FIGS. 183-188 show a PAP system according to certain embodiments;

FIGS. 189A to 189H show a flexible short outlet tube according tocertain embodiments;

FIGS. 190-192 show a patient interface frame and headgear strapconnector connectable to the frame according to certain embodiments;

FIGS. 193A and 193B show an exploded view of a sealing arrangement,including a cushion, and a connector tube according to certainembodiments;

FIGS. 194A and 194B show the sealing arrangement and connector tube ofFIGS. 193A and 193B in a connected state;

FIGS. 195A and 195B show the sealing arrangement and connector tube ofFIGS. 194A and 194B in an extended state;

FIGS. 196A to 196D show a connector tube according to certainembodiments;

FIGS. 197A to 197C show a headworn PAP system according to certainembodiments;

FIGS. 198A to 198D show a connector tube according to certainembodiments;

FIGS. 199A to 199D show a short outlet tube according to certainembodiments;

FIGS. 200A to 200D show exploded views of the connector tube of FIGS.198A to 198D and the short outlet tube of FIGS. 199A to 199D;

FIGS. 201A to 201D show the connector tube and short outlet tube ofFIGS. 200A to 200D in a connected, extended state;

FIGS. 202A to 202D show the connector tube and short outlet tube ofFIGS. 200A to 200D in a connected, unextended state;

FIGS. 203A to 203E show a short outlet tube according to certainembodiments;

FIGS. 204A to 204M show a PAP device, or flow generator assembly,according to certain embodiments; and

FIGS. 205A and 205B show a PAP device, or flow generator assembly,according to certain embodiments.

DETAILED DESCRIPTION

The following description is provided in relation to several embodimentswhich may share common characteristics and features. It is to beunderstood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of theembodiments may constitute additional embodiments.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

1. PAP System

A PAP system (e.g., CPAP system) typically includes a PAP device(including a blower for generating air at positive pressure), an airdelivery conduit (also referred to as a tube or tubing), and a patientinterface. In use, the PAP device generates a supply of pressurized air(e.g. 2-30 cm H20) that is delivered to the patient interface via theair delivery conduit. The patient interface or mask may have suitableconfigurations as is known in the art, e.g., full-face mask, nasal mask,oro-nasal mask, mouth mask, nasal prongs, etc. Also, headgear may beutilized to comfortably support the patient interface in a desiredposition on the patient's face.

Certain embodiments relate to PAP systems in which the PAP device orblower is adapted to be worn on the patient's head, is built into orincorporated into the patient interface or mask, is wearable or carriedby the patient, is portable, is reduced in size or combinations thereof.In certain embodiments, the blower may be of the types described inInternational Application PCT/AU2010/001031, filed Aug. 11, 2010,entitled “Single Stage, Axial Symmetric Blower and Portable Ventilator,”which is incorporated herein by reference in its entirety.

1.1 Certain Embodiments of Headworn PAP Systems

Certain embodiments relate to PAP systems that may be entirely headworn.In certain embodiments, the blower may be mounted on the patient's head(e.g., on the crown of the patient's head or on the front portion of apatient's head).

In certain embodiments, the elbow and external tubing may be removed asthe tubing may run through, or substantially through, the headgear.

In certain embodiments, the blower may be mounted on a cushioncomprising foam to prevent and/or limit transmission of vibration and/ornoise. The foam cushion may include multiple layers of foam ofdifferential hardnesses or densities.

In certain embodiments, the blower may be positioned at variouslocations on the patient's head including, but not limited to, the topregion of the patient's head, the side regions of the patient head, noseregion of the patient's nose, underneath the patient's chin region. Insome embodiments, the blower may be positioned on a portion of thepatient's head between the back of the patient's head and the patient'snose, (e.g., on the top of the patient's head, on the patient'sforehead, in an area between the top and the forehead, on the back ofthe patient's head, in an area between the top and the back of thepatient's head). In addition, in certain embodiments, the blower may bepositioned symmetrically between the left and right halves of thepatient's head or may be positioned asymmetrically between the left andright halves of the patient's head In certain embodiments, the blower,or blowers, may be positioned at various location on the patient's headincluding, but not limited to, the top region of the patient's head, theside regions of the patient head, nose region of the patient's nose,underneath the patient's chin region, between the back of the patient'shead and the patient's nose, on the top of the patient's head, on thepatient's forehead, in an area between the top and the forehead of thepatient's head, on the back of the patient's head, in an area betweenthe top and the back of the patient's head, symmetrically between theleft and right halves of the patient's head, be positionedasymmetrically between the left and right halves of the patient's heador combinations thereof.

In certain embodiments, the blower may be mounted on a front portion ofa patient's head between the crown and the forehead, preferably closerto the patient's forehead.

In certain embodiments, the headgear may include an air channel with noor limited turns in the air path and a 90° turn may be avoided.

Additionally, in certain embodiments, one or more headgear straps (e.g.,constructed of fabric) may be adapted to function as a vent for thesystem.

FIGS. 1A-1C, 2, 3A-3D and 12-23 show headworn PAP systems according tocertain illustrative embodiments.

In FIG. 1A, the patient interface, or mask, system 10 includes a frame20, a cushion 30 provided to the frame and adapted to form a seal withthe patient nose and mouth, and headgear 40 to support the mask inposition on the patient's head. The headgear 40 includes side straps 41,43 and an over-the-head strap 42 that passes between the patient's eyestowards the top of the patient's head. As illustrated, the headgear 40supports a blower 50 in position on the crown of the patient's head. Theover-the-head strap 42 forms a duct to communicate pressurized air fromthe blower to the breathing chamber defined by the cushion. In addition,the headgear includes multi layer foam and/or damping material 49 tosupport the blower 50 and limit vibration/noise. In certain embodiments,the mask may include one or more aspects as described in InternationalApplication PCT/AU2009/000241, filed Feb. 27, 2009, which isincorporated herein by reference in its entirety.

Frame 20 is arranged such that it connects with cushion 30 adjacent itsperimeter or outer most edge. This is so that the appearance of the maskis less obtrusive as the visual impact of the mask will be reduced. Italso enables a clear line of sight to the patient's nares and/or mouthwhen viewed from the front. A short (flexible) tube 51 is coupled withthe cushion 30 to deliver the pressurized air from the blower 50 via theover-the-head strap 42 to the cushion 30. The short (flexible) tube 51may be integrally moulded with the cushion. The short tube 51 may bemade from a sealing material, such as silicone. Frame 20 may includeheadgear connection portions 21 for interfacing with headgear straps 41.As shown in FIG. 1A, headgear is connected to the frame using clips 45.Alternative connection means are possible, such as hooks or slots forreceiving headgear straps, push fit, hook and loop connections, magnets,other connecting means or combinations thereof. Headgear may also beprovided with a cuff, or interfacing means, 55 that is able to be pushfit or otherwise connect with the frame 20. As shown in FIG. 1A,over-the head-strap 42 is provided with a cuff 55, the cuff beingstitched, glued, ultrasonically welded, radio frequency welded,connected by other means or combinations thereof, to the end orconnecting portion of over-the-head strap 42. This interfacing meansthen connects to the frame.

The flexible tubing 51 may be moulded within the over-the-head strap 42and interfacing means to connect with the mask. The flexible tubing 51may alternatively be moulded with the mask, for example as one part withthe cushion, and inserted within the cuff 55 and over-the-head strap 42.The flexible tubing 51 may be formed of, for example, silicone, andintegrally moulded with the cushion.

Over-the-head strap 42 may be constructed of more than one layer ofmaterial. The outer most layer 47 may be a fabric, textile, other softmaterial or combinations thereof for providing comfort when in contactwith the patient's skin. An inner layer 48 may be foam, gel, 3D wovenfabric, other damping material or combinations thereof to absorb noisefrom the air delivery tube. Another inner layer may be a polymer sheetor film 46 (FIG. 3D) to seal the inner portion of the duct so as toprevent air leakage. The polymer sheet may be polyurethane, polyvinyl,another suitable polymer or combinations thereof. Alternatively, theinner portion may be sealed using silicone spraying or a separatelyattachable duct 54 (FIG. 3C). In a further alternative, skinned foam maybe inserted within the outer layer. The portion of the over-the-headstrap contacting the user's face may include additional layers orthicker regions of the damping layer so as to absorb more vibration andnoise.

At the blower connecting end of the over-the-head strap 42, a secondcuff or connecting means 53 may be provided to connect the blower outletto the headgear 40. The cuff 53 may be formed of a polymer that may be athermoplastic elastomer, thermoplastic urethane, polyester,polypropylene, other suitable materials or combinations thereof. Thecuff 53 may be glued or integrally formed with the over-the-head strap42.

The blower mounting portion of the headgear may include a cradle orpositioning means to capture the blower, stabilize it in position, andpreferably absorb noise and/or vibration. The blower mounting portion ofthe headgear may include additional layers of damping materials 49 suchas foam, silicone, gel, 3D textiles, other suitable damping materials orcombinations thereof.

The blower may have an air intake or inlet portion 52 positionedparallel to the top portion of the patient's head (as shown in FIG. 1A).Alternatively, the inlet may be positioned normal or perpendicular tothe top portion of the patient's head. Alternatively, the inlet may bepositioned at other angles between normal and perpendicular to the topportion of the patient's head.

FIG. 2 shows a mask according to certain embodiments. Here, the patientinterface of FIG. 2 includes a nasal cushion 130 and the frame 120includes an alternative configuration for attaching lower headgearstraps 141, as compared to that shown in FIG. 1A.

Lower headgear connectors 121 may be slots or loops to receive loops ofheadgear straps 141. Slots may be connected to arms or wings 122 thatmay move the connection point of the headgear to the frame 120 away fromthe patient's line of sight.

In FIGS. 3A to F, the patient interface includes a nasal prong or pillowarrangement 230 adapted to form a seal with the patient's nares. Theheadgear 240 includes side straps 244 that form ducts to communicatepressurized air from the blower to the nasal prong arrangement. Incertain embodiments, the headgear and/or mask may include one or moreaspects as described in WO 2009/052560 A1, U.S. Patent ApplicationPublication 2009/0044808 A1, and/or U.S. Pat. No. 7,318,437, each ofwhich is incorporated herein by reference in its entirety.

Cushion 230 may include a plug or vent clip 231 to seal the cushion. Inorder to manufacture the pillows on cushion 230, the core 232 may beremoved through the aperture as shown in FIG. 3E. Alternatively, theplug 231 may include vent holes to provide venting to the maskarrangement. FIG. 3E shows the cushion 230 with the floating core 232and the aperture from which the core has been removed as indicated bythe arrow.

Headgear straps 244 may be attachable to the cushion 230. Headgearstraps 244 may be ducted or hollowed to enable the passage of gasthrough the straps. The cushion connecting ends of the headgear straps244 may include cuffs, or connecting means, 233 to enable removal of thecushion from the headgear. The cuffs may be moulded, glued, radiofrequency welded, ultrasonically welded or otherwise attached to thecushion connecting ends of the headgear straps 244.

The headgear straps 244 may include more than one layer. The outer mostlayer 47 may include a soft, comfortable material such as fabric, foam,frosted polymers, other suitable materials or combinations thereof. Aninner layer 48 may comprise a damping material such as foam, gel,silicone, 3D textiles, other suitable materials or combinations thereof.The headgear straps 244 may be constructed using ultrasonic welding,thermoforming or combinations thereof. An inner most portion of theheadgear straps 244 may include a sealed, ducted portion 54 fortransmitting gases from the blower to the cushion. This may beconstructed from an extruded silicone tube, a helical tube, apolyurethane tube or a combination thereof.

The top portion of the headgear may include a transition portion, orconnecting portion, 56 for joining the headgear straps 244 to theblower. Transition portion 56 may include a substantially W-shapedportion as shown in FIG. 3F, wherein there are two outer portions forconnecting with the side straps or ducts within headgear straps 244, anda central connecting portion 58 for connecting with the blower via cuff53. This transition portion may be integrally formed with the headgear,for example by thermoforming, ultrasonic welding, gluing, otherconnecting means or combinations thereof. In alternative embodiments,the transition portion may be positioned within or on the headgearwithout permanent fixation. The transition portion may be made ofsuitable sealed materials, for example silicone, TPE, TPU,polypropylene, polycarbonate, or other suitable materials. Thetransition portion may sealingly engage with headgear ducts and theblower. The transition portion and headgear ducts may sealingly engageby interference fit. Alternatively, they may be formed in one piece. Thetransition portion and blower may sealingly engage by interference fit,such as push fit.

FIGS. 12-23 show alternative configurations for communicatingpressurized air from the blower to the mask, alternative frameconfigurations for attaching headgear, alternative headgeararrangements, and/or alternative cushion or sealing arrangements,according to certain embodiments.

FIG. 12 shows a blower 50 positioned on the top or at the apex of thepatient's head that is substantially held in position by a headgear 40.The headgear may include a securing portion 44 for maintaining theblower in position on the headgear. The securing portion may include aformed region that holds the blower in compression to substantiallymaintain it in position. Alternatively, the securing portion may includea sock, clip, wrap, other suitable structure, or combinations thereof tomaintain the blower in position. The headgear may further include achannel, or hollow region, 39 to pass a tube from the blower outlet tothe mask. The channel or hollow region may extend along the length ofthe tube or a portion thereof. The channel may maintain the heat withinthe tube. The channel may also make the system appear more streamlined.The channel may further dampen and/or prevent the flow of noise from theblower to the mask 10. The mask 10 may include a cushion 30 and a frame20. The mask may further include lower headgear connection points 21.The lower headgear connection points may include clips, loops or otherheadgear connection mechanism.

FIG. 13 further demonstrates an arrangement for mask and blower system,where there are at least two blowers positioned at the top or apexregion of the patient's head. Each blower may connect to a tube 59,where the tube then connects to the mask system. Preferably, the tubesconnecting the blowers and the mask are positioned under or encapsulatedwithin the headgear straps. The embodiment shows two blowers, however itis possible for more than two blowers to be positioned on the headgear.

FIG. 14 shows an alternative arrangement to the embodiment shown in FIG.13. FIG. 13 shows a full face mask or mask that seals around at leastthe nose and mouth of a patient. The embodiment shown in FIG. 14 shows amask 10 that seals around a nose region of a patient. In addition, themask includes a frame 20, where the frame may be a skeleton frame or aframe that surrounds the perimeter of the mask without shrouding orcovering the central portion of the mask. This may make it easier to seethe patient's nares when the system is in use. Such an arrangement maybe beneficial in a clinical setting where a view to the patient's naresis desirable. In addition, the frame includes outriggers, or slenderextensions, 22 from the frame to the headgear connecting portions 21 toreduce the visual bulk of the mask. In addition, the outriggers may alsoenable greater flexibility at the headgear connecting portions. Suchflexibility may be desirable to enable greater sealing engagement of themask with the patient.

FIG. 15 shows a full-face mask according to certain embodiments. Theblower 50 is positioned at the top or apex of the patient's head. Theintake of the blower housing is rearward facing, that is, facing in ahorizontal direction away from the patient's face. It may also bepossible for the intake of the blower housing to be positioned inalternative orientations, such as directly vertical. The headgear mayinclude a channel or hollow region 39 for positioning of a tube, thetube being attached to the outlet of the blower housing and the mask 10.The headgear channel 39 may terminate at a cuff, or connecting means, 55where the mask frame 20 has an opposition cuff, or connection means, 25for engagement with the headgear channel. The connection may be amechanical connection such as a snap fit, a taper lock, a permanentchemical connection, moulded in one piece or combinations thereof. Theframe may be of a skeleton or perimeter arrangement similar to thatshown in FIG. 14.

FIGS. 16A to 16C show an alternative arrangement, where the patientinterface 10 is a pillows or prongs type mask. The patient interface isfluidly connected or a part of a tube arrangement 61, where the tubesare routed or positioned on each of the patient's cheeks and between thepatient's eyes and ears. The tubes terminate or connect to a blower orblower housing, positioned at the top or apex of the patient's head. Theheadgear 40 may encapsulate or otherwise surround the tubes as shown inFIG. 16C. The headgear may be formed with the tubes or may beretrospectively fit or placed around the tubes. As shown in FIG. 16B,the tubes may be radio frequency welded within a thermoformed fabric,for example.

FIG. 17 shows an alternative pillows or prongs type mask 10, where thetube 59 is routed directly vertical or upwards of the patient's head.That is, the tube is positioned in use between the patient's eyes. Themask 10 may connect to the headgear 40 on its lateral sides by push fittabs, hook and loop, or any other engagement mechanism 12. The mask 10may have an orifice 11 for venting on its lower portion, directlyopposite the position or attachment points of the prongs or pillows.This may be to facilitate: manufacture.

FIG. 18 shows further embodiments where by allowing the core to beremoved from the pillow or prong mask as described in relation to FIGS.3A to 3D, then the hollow air path within the pillow or prongs isproduced. This embodiment includes many attributes of the systemdescribed in FIG. 15. The skeleton or minimized frame 20 in thisembodiment has a top portion 23 that is generally upside down T-shaped.The upper stem 24 of the T-shaped portion 23 loops or wraps around thetube 59. Lower headgear connectors 21 are positioned on the lowerportion of the minimized frame.

FIG. 19 shows alternative embodiments. The mask 10 may have sideconnectors 26 to a tube, or tubes, where the tubes 27 are directed orpositioned along the patient's cheeks and between the patient's eyes andears. The tubes 27 terminate or connect at the blower 50, and connect tothe rear or inferior side of the blower or blower housing. The rear orinferior side of the blower is generally opposite the side of the blowerfacing the same direction as the face of the patient. This may enhancethe stability of the system by cupping or embracing the rear of thepatient's head in use.

FIG. 20 shows further alternative embodiments. The mask 10 may have atube connecting portion 28 at the top or apex of the mask. The tube 29may bifurcate at the forehead region of the patient. There may be awebbing, or mesh, 19 at the junction or separation point of the tube 29to prevent the bifurcated tube from splaying to far outward. Thebifurcated tubes may then enter or connect to the outlet of the blower50 or blower housing.

FIG. 21 shows further alternative embodiments. The mask 10 is a fullface mask having an alternative configuration for attaching lowerheadgear straps.

FIG. 22 shows further embodiments. An alternative patient interface 10,being a nasal cradle 13, may have a tube connecting portion at the frontof the nasal cradle cushion 13 that delivers the pressurized air fromthe blower 50 directly into the front of the nasal cushion. A tube 59 isrouted directly vertical or upwards of the patient's head from tubeconnecting portion 15 to the blower 50 positioned on the patient's head.That is, the tube is positioned in use between the patient's eyes.Headgear side straps 41 support the positioning of the nasal cradle onthe patient's nares.

FIG. 23 shows an alternative patient interface 10, being a nasal cradle13. The nasal cradle 13 may include a single orifice to deliverbreathable gas to both nares of the patient, with the outer walls 14engaging an outer region of the nose of the patient.

FIGS. 56-67 show headworn PAP systems according to certain embodiments.In each embodiment, the blower 50 is supported by one or more headgearstraps 43 on top of the patient's head, and communicated with thepatient interface 10 via an over-the-head (e.g., see FIGS. 56-59) or topto side of head (e.g., see FIGS. 60 and 61) air delivery tube 65.

The blower and its housing utilized in these embodiments have a widerrange of usage requirements than typical blowers. For example, theblower may be headworn so it may therefore be positioned at variousangles through the night as the patient rolls around in their sleep.Therefore, the blower may need to function at multiple axes oforientation. The blower may suffer from gyroscopic effects. The life ofthe components may be affected by the additional movement and thereforeloading of the parts. In addition, when directly coupled to the head,the blower may vibrate which may not only be uncomfortable to thepatient but may also have physiological effects. Accordingly, certainembodiments may have a wider range of usage requirements than typicalblowers. Certain embodiments may be configured such that the blower maybe positioned at various angles through the night as the patient rollsaround in their sleep and still suitably function. Certain blowers maysuitably function at multiple axes of orientation. Certain blowers maysuitably function such that effective life of the components may beobtained. Certain embodiments may be configured such/that the effects ofvibration and/or noise are suitable dampened and the patient iscomfortable and does not suffer from physiological effects in use.

In FIGS. 56-61, the blower is supported in spaced relation from thepatient's head by a pedestal or support structure 185, which maydecouple or isolate the blower from the patient's head in use, e.g., todampen vibrations as discussed below. In FIGS. 62-67, at least portionsof the blower and air delivery tubing are enclosed or covered by asheathing material 195, which may dampen noise and vibrations from theblower in use.

In certain embodiments, the blower housing may be adapted to include“wings” on either side of blower housing. The wings would not impinge onthe aesthetic size or bulk of the device from the wearer's perspective,but may greatly increase the volume of the muffling body of the blowerhousing. For example, FIGS. 123A-129 illustrate alternative examples ofa blower housing or flow generator having a front outlet and side airintake filters. In certain embodiments, headgear may be attached to thesides of the flow generator or blower housing to support the flowgenerator in position. The headgear may be attached to the flowgenerator using connection structures (e.g., slots) for attachingheadgear straps.

FIG. 123A shows an embodiment where the flow generator includes sideintake filters positioned near the front the flow generator and a frontfacing outlet tube, the headgear straps extend from each side of theflow generator. FIG. 123B is an alternative embodiment showing sideintake filters in a more central location along the side of the flowgenerator. A front outlet tube and back headgear attachment is provided.The tapered design provides a blending from the back of the flowgenerator to a low point towards the hack of the head to remove visualbulk.

FIGS. 124 and 126 is a flow generator embodiment showing headgearattachment blending up to the flow generator or blower housing to softenthe height of the blower. The tapered sides of the flow generator reducethe visual bulk of the housing by angling down and rounding the topedges. The headgear strap extends from the back of the flow generator orblower housing.

FIGS. 125 and 127 are top views of embodiments of an assembly comprisinga flow generator mounted on to a headgear. The blower is central andshown as a circle. The horizontal portions directly adjacent the blowerare muffling volume. These extend on to the crown strap of the headgear.The vertical portion has an inner tube that is the outlet portion, andtwo adjacent portions that are the inlet

FIG. 128 is an isometric view of the assembly shown in FIG. 127. Themuffling volumes resemble wings extending from the central blower. Thewings include slots for receiving the headgear straps. Alternatively,the blower housing could be coupled directly to the headgear so theseslots would not be necessary. The outlet is the round tube, having theinlet portions immediately adjacent and on the sides of the outlet. Thisis a streamlined, visually unobtrusive design.

FIG. 129 is an embodiment showing tapered sides blending into headgearstraps and back of the patient's head to reduce the step change orheight difference. An intake filter may also be located on the top frontsection (not shown).

1.1.1 Certain Embodiments of the Blower Isolation

As noted above, mounting the blower on the patient's head (e.g., on thepatient's crown) may allow vibration noise to be transmitted directly tothe skull of the patient. Also, the headgear straps may transmit noiseto the patient's skull in use. The following provides alternativeexamples of a blower support structured to decouple or isolate theblower from the patient's skull so as to dampen vibrations in use.

In certain embodiments, it may be desirable that the blower not radiateheat to a level that the patient cannot tolerate or is dangerous. Incertain applications, the blower may not produce sustained temperaturesover 60° C. In certain applications, the blower may not producesustained temperatures over 30° C. In certain embodiments, the blowermay produce sustained temperatures under at least 60° C., 50° C., 40°C., 35° C. or 30° C.

1.1.1.1 Certain Embodiments of the Blower Inflatable Cushion

FIGS. 68A and 68B illustrate a blower support in the form of aninflatable cushion 85 (e.g., constructed of silicone or TPE) adapted tosupport a blower 50 on the patient's head in use. The blower iscommunicated with an inflatable chamber 86 of the cushion so thatpressurized air from the blower is directed into the chamber to inflatethe cushion 85, and thereby lift the blower from the patient's head. Airfrom the blower may flow through the cushion 85 and into the airdelivery conduit in communication with the patient interface, or airfrom the blower may be ported to the inflatable chamber. The inflatedcushion isolates (e.g., vibration isolation) the blower from itssurroundings (i.e., patient's head, headgear, and air column in the airdelivery tube). The inflated cushion may also act as a volume muffler.In certain embodiments, the inflated cushion may isolate vibration fromthe blower from its surroundings and may also act as a volume muffler toreduce noise. In certain embodiments, the inflated cushion may isolatevibration from the blower from the patient's head, headgear, air columnin the air delivery tube or combinations thereof and may also act as avolume muffler to reduce noise.

In addition, the cushion 85 may provide headgear connectors 90 onrespective sides thereof that are adapted to attach to respectiveheadgear straps for supporting the blower on top of the patient's headin use.

As illustrated, the cushion 85 defines a recess or nest 88 adapted toreceive the blower. The nest may be turned inside out to facilitateassembly of the blower into the cushion. When assembled, the silicone orTPE cushion 85 forms seals along the inlet 52(1) and outlet 52(2) of theblower. A sealing lip may be added to the blower to assist sealing.

1.1.1.2 Certain Embodiments of the Web Arrangement

FIG. 69 illustrates a blower support. The blower support may include agel or silicone skin 285 adapted to support a blower 50 on the patient'shead in use. The gel or silicone skin decouples the blower from itssurroundings, e.g., skin acts as a web to support the blower in spacedrelation from the patient's head.

As illustrated, the blower support includes a headgear connector 290adapted to attach to respective headgear straps, spaced-apart arms 287extending upwardly from the headgear connector, and the skin 285 whichis supported by the arms 287. The skin includes an opening adapted toreceive and retain the blower 50 therewithin. Also, the headgearconnector may include one or more moulded hinges 292 (e.g., constructedof silicone, rubber, TPE) to prevent vibration transmission along theheadgear connector and to the headgear straps.

FIGS. 70-72 illustrate a blower support including a web-like ortrampoline-like arrangement 385 adapted to support the blower in spacedrelation from the patient's head in use.

As illustrated, the blower support 385 includes a headgear connector 390adapted to attach to respective headgear straps, spaced-apart arms 387extending upwardly from the headgear connector, and a plurality ofsupport members 385 to interconnect the arms with the blower 50 so as tosupport the blower in spaced relation from the headgear connector (e.g.,blower spaced from the headgear connector by a gap G).

The support members 385 are constructed of a resilient material (e.g.,silicone, rubber, TPE) to dampen vibrations and form a web ortrampoline-like arrangement that allows the blower 50 to oscillatewithin the gap and hence dampen and isolate vibrations from thepatient's head in use. The support members 385 may be formed as separateparts and attached between the blower 50 and arms 387. Alternatively,the support members may be moulded onto the blower 50 (e.g., co-moulded,two-shot transfer) and then attached to the arms 387 (e.g., end of eachsupport member 385 includes a head 385(1) structured to retain thesupport member within a respective slot or opening formed in the arm 387as shown in FIG. 72).

Also, the wings or end portions 390(1) of the headgear connector (i.e.,including slot for engagement with respective headgear strap) may beconstructed of a resilient material (e.g., silicone, rubber, TPE) toprevent vibration transmission along the headgear connector and to theheadgear straps.

The web arrangements may also include combinations of materials.

1.1.1.3 Certain Embodiments of the Damping Support Structure

FIGS. 73 and 74 illustrate a blower support including a dampingstructure 485 adapted to support a blower 50 on the patient's head inuse. The damping structure 485 is constructed of a vibration dampingmaterial (e.g., silicone, gel, foam, air cushion or bladder, spacerfabric, etc.) structured to dampen vibrations from the blower in use.The damping structure may also be constructed of combinations ofvibration damping materials.

As illustrated, the blower support includes a headgear connector 490adapted to attach to respective headgear strap and the damping structure485 to support the blower 50. The headgear connector may includesections 492 constructed of vibration damping material to preventvibration transmission along the headgear connector and to the headgearstraps. In addition, further vibration damping material may bepositioned along the underside of the headgear connector, e.g., alongthe side adapted to contact the patient's head in use.

1.1.1.4 Certain Embodiments of the Damping Headgear

FIG. 75 illustrates headgear 585 adapted to support a blower on thepatient's head in use. The headgear includes one or more portionsconstructed of a vibration damping material (e.g., gel, TPE, foam, aircushion or bladder, liquid, silicone, rubber, etc.) to dampen vibrationsform the blower in use. The headgear may also include combinations ofvibration damping materials.

In the illustrated embodiment, the headgear 585 includes a plurality ofstraps, i.e., upper side straps, lower side straps, top strap, rearstrap. As illustrated, one or more selected portions of the strapsinclude a bladder or pocket of vibration damping material 586. Forexample, spaced apart bladders may be provided along the top and rearheadgear straps. However, the headgear may include other suitablebladder arrangements.

Each strap may be constructed of a multi-layered, composite material(e.g., such as Breathe-0-Prene™) including outer fabric layers 587(1)and an inner foam layer 587(2), e.g., see FIGS. 76 and 77. As shown inFIG. 76, the bladder 586 may be inserted into a pocket or recess formedin the foam layer 587(2). Alternatively, as shown in FIG. 77, thebladder 586 may be attached (e.g., adhered, welded, etc.) to the fabriclayer 587(1) oriented towards the patient's skin in use.

1.1.1.5 Certain Embodiments of the Damping Support Structure withinBlower

FIGS. 78-80 illustrate alternative examples of a blower including adamping structure (e.g., constructed of a vibration damping materialsuch as silicone, gel, TPE, rubber, etc.) adapted to dampen vibrationtransmission from the motor to the outer casing or housing. The supportstructure within the blower may also include combinations of vibrationdamping materials. As illustrated, each blower 50 includes an outercasing or housing 155, a stator component 156 positioned within andsupported by the outer casing, and a motor 157 positioned within thestator component and adapted to drive an impeller 158. The statorcomponent 156 includes first and second parts 156(1), 156(2) coupled toone another by an O-ring 156(3), which decouples the first and secondparts to dampen vibrations from the first part to the second part.

In FIG. 78, the damping structure is in the form of a jacket 685positioned between the motor 157 and the second part 156(2) of thestator component. In use, the jacket is structured to prevent vibrationsfrom be transmitted to the stator component and on to the outer casing.

FIG. 79 shows a similar arrangement to FIG. 78. In contrast, a seconddamping structure 687 is provided between the second part 156(2) of thestator component and the outer casing 155 to enhance the damping effect.In certain embodiments, the second damping structure may be overmouldedonto either the stator component or the outer casing.

In FIG. 80, the second part 156(2) of the stator component isconstructed of a vibration damping material (e.g., TPE, silicone,rubber, or other suitable rubberized vibration isolating material). Sucharrangement provides a relatively “soft” stator component to dampenvibration transmission from the motor 157 to the outer casing 155 inuse.

1.1.1.6 Certain Embodiments of the Damping Support Structure EncasingBlower

FIGS. 81-85 illustrate alternative examples of a blower including adamping structure configured to encase or enclose the blower, therebydamping vibrations and muffling noise from the blower in use. In certainembodiments, a blower may include a damping structure configured to atleast partially encase or enclose the blower, thereby damping vibrationsand muffling noise from the blower in use. The support structureencasing the blower may also include combinations of damping materials.

In FIGS. 81 and 82, the damping structure is in the form of an outerhousing 785 including first and second housing parts 785(1), 785(2)coupled to one another, e.g., by a joint. As illustrated, the base ofthe second housing part 785(2) includes a cuff 788. The cuff includes afirst portion 788(1) adapted to engage the outlet 52(2) of the blower 50so as to support the blower within the housing interior. The secondportion 788(2) of the cuff is adapted to engage the air delivery tube760 structured to deliver pressurized gas from the blower to the patientinterface. The damping structure is constructed of a vibration dampingmaterial adapted to dampen vibrations and/or muffle noise from theblower in use.

In FIGS. 83 and 84, the damping structure includes a single housing part885 (e.g., constructed of a vibration damping material) that at leastpartially or fully encases the blower 50. In addition, damping supportstructures 888 (e.g., constructed of a vibration damping material suchas TPE. TPU, silicone, etc.) are provided between the blower and thehousing part to support the blower within the housing part and enhancethe damping effect. In certain embodiments, the damping supportstructures may be overmoulded onto the blower.

In FIG. 85, the blower is encased or enclosed within a casing 985constructed of a vibration damping material (e.g., rubber or othersuitable materials). The casing may be overmoulded onto the blower, orformed separately from the blower and then assembled onto the blower. Asillustrated, the base of the casing includes a plurality of supports orfeet 986 (e.g., conical supports) structured to support the casing onheadgear (as described below) and create an air gap between the casingand the headgear to dampen vibrations.

In the illustrated embodiment, the headgear strap 987 adapted to supportthe casing 985 (and blower therewithin) includes a thermoformed,multi-layered, composite material including outer fabric layers 987(1)and an inner foam layer 987(2). As illustrated, a damping insert orbladder 988 (e.g., constructed of foam, gel, liquid, moulded silicone,TPE, TPU, spacer fabric, etc.) may be inserted into a pocket or recessformed in the foam layer. Also, the headgear strap may include arecessed portion 989 adapted to receive and position the casing 985 onthe headgear strap.

1.1.1.7 Certain Embodiments of the Blower with Silicone Bladder

FIG. 86 illustrates a blower 1210 according to another embodiment. Inthis embodiment, a portion of the housing is formed of silicone whichacts as a vibration isolator and/or outlet muffler in use.

The blower 1210 includes a housing 1220 with first and second housingparts 1222, 1224, a stator component 1230, a motor positioned within thestator component 1230 and adapted to drive a rotatable shaft or rotor(not shown), a PCBA 1290 for motor control, and an impeller 1260provided on one side of the stator component 1230 and adapted to becoupled to an end portion of the rotor. In addition, the blower mayinclude an outer housing structure 1205 communicated with the inlet 1226and structured to act as a muffler for incoming air.

In the illustrated embodiment, the first housing part 1222 provides theinlet 1226 and the second housing part 1224 provides the outlet 1228.The first housing part 1222, second housing part 1224, and statorcomponent 1230 cooperate to define the volute 1270 that directs airtowards the outlet. Also, the first housing part 1222 provides aseparating wall 1223 that separates the volute 1270 into two regions,i.e., a high speed airpath region 1270(1) and a low speed airpath region1270(2). The first and second housing parts 1222, 1224 may provide ajoint 1225 (e.g., tongue and groove arrangement) to facilitate alignmentand/or connection.

Moreover, the second housing part 1224 (which provides an exteriorportion, outer wall portion, or pressure side of the volute) is formedof a silicone material. This arrangement allows the second housing part1224 to act as an air cushion or bladder in use, e.g., second housingpart may at least partially inflate when pressurized in use. In use, thesilicone second housing part 1224 supports the first housing part 1222,stator component 1230, motor, and impeller 1260 in a flexible,vibration-isolated manner. Thus, vibrations and/or other movementgenerated by these components in use are substantially isolated, e.g.,from the outer housing structure 1205. Moreover, the silicone secondhousing part 1224 acts a muffler for air exiting the outlet 1228 in use.The second housing may include barbs or stilts to act as shockabsorbers. The barbs may be continuous with the bladder or separatelyattached.

Thus, the silicone second housing part prevents vibration conductioninto the patient's skull, vibration conduction into the headgear, andnoise conduction down the air delivery conduit. In certain embodiments,headgear may attach directly to the bladder or to the outer housingstructure (if provided).

In the illustrated embodiment, the stator component 1230 includes firstand second parts 1231(1) 1231(2) that are coupled to one another, e.g.,by a joint. The first and second parts cooperate to define a hollowinterior adapted to support and maintain the motor and rotor in anoperative position. Also, the first and second parts of the statorcomponent are structured to retain bearings 1252, 1254 that rotatablysupport the rotor. For example, the first part 1231(1) may include arecess for supporting one bearing 1252 and the second part 1231(2) mayinclude a recess for supporting the other bearing 1254. The first andsecond parts may be structured to support bearings of the same or mixedbearing sizes. In addition, the first part provides an opening along itsaxis that allows the end portion of the rotor to pass there through forengagement with the impeller 1260.

The outer housing structure 1205 includes a base 1206 that extendsaround the exterior of the second housing part 1224, and a cover 1207that encloses the top of the blower including the inlet 1226. The base1206 provides an inlet 1208 with an inlet chamber 1209(1) to reduce atleast a portion of the noise produced by incoming air. In addition, thecover 1207 provides a small chamber 1209(2) downstream from the inletchamber to muffle noise entering the inlet 1226.

In certain embodiments, foam or gels may also be used in one or moreportions of the blower to muffle noise and vibration. The foam may bepositioned to fill any open volumes in the blower housing to stabilizethe blower in position in the housing and to absorb vibration, noiseand/or frequency of noise. The foam may be an open cell foam, a closedcell foam, or combinations thereof. The foam may be skinned orunskinned. The foam may also be utilized to space or position the inletof the blower away from the wall of the housing to prevent the blowerfrom choking and to prevent the blower from sucking itself on to thehousing wall.

In certain embodiments, the blower may be structured to providepressurized air in the range of 12-14 cmH₂0, about 25000 rpm, and flowrate of about 80-100 L/min.

In certain embodiments, as shown in FIG. 86, Hl may be about 30-35 mm(e.g., less than 35 mm, 31 mm), H2 may be about 10-20 mm (e.g., lessthan 20 mm, 14 mm, 18 mm), W1 may be about 80-90 mm (e.g., less than 90mm, 83 mm), W2 may be about 65-7 5 mm (e.g., less than 75 mm, 69 mm),and W3 may be about 40-50 mm (e.g., less than 50 mm, 44 mm, 41 mm).However, other suitable dimensions are possible.

In alternative embodiments, the blower may be suspended from the topcase of the blower housing by a skin or bladder. The bladder may beconstructed of a polymer or other flexible material. For example, thebladder may be constructed of a silicone or thermoplastic elastomer(TPE). The silicone may be about 5-.70 Shore A. The TPE may be about5-70 Shore 00. The bladder may have varying wall thicknesses. Forexample, the region adjacent the top cover of the blower may be thinnerthan the region proximal to (but not attached to) the bottom case of theblower housing. This may be to support the weight of the blower at aregion of the bladder and allow flexibility at a region of the bladder.Preferably, the thickness of the thicker region of the bladder may beapproximately 2-5 mm. Preferably, the thickness of the thinner region ofthe bladder may be less than 2 mm. Suspending the blower from the topregion of the blower may increase the distance of the blower to thepatient, thereby reducing noise and vibration effects. The bladder mayspace the lower portion of the blower from the bottom region of theblower housing to enable air intake into the blower,

In additional embodiments, the bladder suspending the blower from thetop portion of the blower housing may have an outer side wall or walls.The outer side walls may be positioned on a side wall surface notadjacent the blower, that is, the outer side walls are external to theblower. These walls may include barbs or shock absorbers on the outerface of the side wall. The barbs may deform when in contact with anotherregion of the blower housing. The barbs may prevent or reduce thetransmission of forces from the blower and/or motor and/or prevent orreduce the transmission of vibration to the blower housing. The barbsmay be a conical or cylindrical shape. Other shapes may also be used ifsuitable. The length of the barbs may vary, for example, the barbs maybe approximately 2 mm long. The barbs may be constructed of an elasticmaterial or other suitable materials so that they can substantiallyrecover to their original shape after being loaded, so that they mayabsorb a second force or further forces. The barbs may be constructed ofa viscoelastic material. The barb or shock absorber may be a singlecontinuous skirt around the bladder. The barbs or shock absorbers mayalso comprise multiple, individually spaced or combinations thereof,discrete elements around the bladder.

1.1.2 Certain Embodiments of the Motor Isolation

Electromagnetic waves may be transmitted directly to the patient due tothe direct coupling of the motor to the patient. A shunt gate may beadded to the motor to shield the patient from the electromagneticfluxes. The shunt gate may be a ferrous material positioned between thepatient and the motor.

In addition, in certain embodiments, the motor may be positioned as faraway from the patient as the configuration or set up of the system willallow. For example, the arrangement shown in FIG. 86 shows the blowerpositioned such that the motor will be close to the patient's head.However, it may be possible to turn the blower upside down or 180°rotated so that the motor is positioned further away from the patient'shead to reduce the effects of electromagnetic radiation.

1.1.3 Certain Embodiments of the Blower Inlets

The blower may be provided with an inlet or inlets. In addition toinlet(s) on the blower, the blower housing may include an inlet orinlets.

In certain embodiments, the blower and blower housing inlets may beconfigured so as to minimize occlusion by bed clothing or other items asthis may choke the blower. The inlets of the blower housing may bepositioned on the same plane as the face of the patient when in use.Alternatively, the inlet or inlets of the blower housing may bepositioned at the top or superior position such that its radial axis issubstantially vertically upwards. Alternatively, the blower housinginlets may be towards the lateral or side portions of the blowerhousing. In this arrangement there may be multiple inlets so that if thepatient rolls on to their side and occludes one or more inlets, otherinlets positioned opposite or distal from the occluded inlets will stillbe open for receiving air. Other suitable arrangements may also be used.

The blower or blower housing inlet(s) may have a filter (for example, afibrous filter or a foam) to filter incoming gases.

The blower and/or blower housing inlet may further have a snorkel orlead-in, to extend the length of the air path coming into the blower.The longer the air path to the blower, the more laminar the flow of thegases and therefore the quieter the system. The snorkel or lead-in mayfurther alter the position of the air intake or inlet, to a positionthat is unlikely to be occluded. For example, the blower inlet may bepositioned at the rear or back portion of the blower or blower housing.If the patient is lying on their back, it is likely that such an inletmay be occluded by bed clothes, or a pillow. A snorkel or inletextension may therefore be provided to this inlet position to alter thedirection of this air inlet. Alternatively, a snorkel or extended inlettube may be provided to position the inlet away from the patient's ears.Alternatively, a snorkel or extended inlet tube may be provided toposition the inlet away from the patient's hair.

The inlet and/or snorkel may have rounded edges to allow the smooth flowof gases into the inlet.

The air inlet may have a substantially oval or circulate cross section.This profile may have a lower noise output than a square inlet forexample. However, other suitable cross sections are possible.

The inlet to the blower may be spaced away from the blower housing ormuffler. In certain aspects, there may be, for example, at least a 10 mmgap between the inlet to the blower and the housing wall. In certainaspects, there may be, for example, at least a 5 mm gap between theinlet to the blower and the housing wall. In certain aspects, there maybe, for example, at least a 2 mm gap between the inlet to the blower andthe housing wall. This is to prevent or minimize choking the blower.

The cross section of the inlet or inlets of the blower housing may besufficient to ensure the function of the blower, that is, to avoidchoking the blower. The inlet(s) of the blower housing may have a crosssection that may be equal to or greater than the cross section of theoutlet of the blower. In an exemplary embodiment, the cross section ofthe inlet(s) may be 150-400 mm². Preferably, the cross section of theinlet(s) may be 100-200 mm².

1.1.4 Certain Embodiments of the Blower Outlet

The blower may have an outlet or air exhaust, for delivering thepressurized gas to the air delivery tube. The outlet of the blower maybe coupled to the housing or muffler by a coupling tube. The couplingtube may be flexible. The couple tube may be made of a polymer, such assilicone. The wall of the coupling tube may be 1.5 mm thick. Preferably,the wall of the coupling tube may be less than 5 mm. Most preferably,the wall of the coupling tube may be less than 2 mm. The coupling tubemay prevent or minimize the blower from movement or travel within thehousing. The coupling tube may act: as a dipole cancellation or absorbvibration from the blower. The coupling tube may prevent hard couplingof the blower to the blower housing, thereby preventing or minimizingthe transmission of vibration or noise to the blower housing.

The outlet of the blower housing may be coupled to an air delivery tube.The air delivery tube connects the blower housing to the patientinterface. The outlet of the blower housing may include a connectionring or portion of a tube for connection or coupling with the airdelivery tube. The connection ring may interface with the air deliverytube by mechanical means such as a taper lock, push fit, snap fit orother suitable means.

In a further alternative, the tube connecting the outlet of the blowermay directly couple to the air delivery tube, such that there is nointermediate connection with the blower housing.

1.1.5 Certain Embodiments of the Blower Housing

The blower may be positioned in housing or positioned in a dampingstructure to reduce noise output from the device and to position theblower on the patient. In certain embodiments, the housing should be thelargest volume possible to muffle noise output from the blower, howevershould also be the smallest volume possible to reduce the weight andsize of the system to reduce visual bulk and avoid discomfort to thepatient.

In certain embodiments, the blower may be small and compact so as tominimize the obtrusiveness and increase the comfort of the system. Theblower may be constructed and arranged to have an axial inlet and atangential outlet to minimize the size of the blower. Alternatively, theblower may be constructed and arranged to have an axial inlet and anaxial outlet to minimize noise.

In certain embodiments, the height of the blower or blower housing maybe as minimal as possible to reduce the visual bulk of the system andminimize the moment or torque produced by the component. In certainembodiments, the height of the blower or blower housing may be asminimal as possible to reduce the visual bulk of the system. In certainembodiments, the height of the blower or blower housing may be, forexample, less than 100 mm, less than 80 mm, less than 60 mm, less than40 mm, or less than 20 mm. In certain embodiments, the height of atleast a portion of the blower or at least a portion of blower housingmay be, for example, less than 100 mm, less than 80 mm, less than 60 mm,less than 40 mm, or less than 20 mm.

In certain embodiments, the volume of the housing may be, for example,less than 350 cm³, less than 300 cm³, less than 250 cm3 or less than 200cm³.

In certain embodiments, the blower housing including the blower andexcluding the weight of the batteries may weigh, for example, less than500 g, less than 300 g, less than 250 g, less than 200 g, or less than150 g.

In certain embodiments, the noise output by the blower and housing maybe, for example, less than 70 dBA, less than 60 dBA, less than 50 dBA,less than 46 dBA, or less than 40 dBA. In certain embodiments, the noiseoutput by the blower and housing may be approximately between 44-46 dBA.In certain embodiments, the noise output by the blower and housing maybe, for example, about 37-45 dBA. In certain embodiments, the noiseoutput by the blower and housing may be less than 40 dBA. In certainembodiments, the noise output by the blower and housing may be, forexample, between 30 dBA and 70 dBA, 35 dBA and 60 dBA, 40 dBA and 60dBA. 40 dBA and 50 dBA, or 43 dBA and 46 dBA.

In certain embodiments, the wall thickness of the housing or muffler maybe optimized for noise and/or vibration damping as well as weight andsize. In certain embodiments, the wall thickness of the housing ormuffler may be, for example, less than 8 mm, less than 7 mm, less than 5mm, or less than 3 mm. In certain embodiments, the wall thickness of thehousing may be, for example, 3 mm. In certain embodiments, the wallthickness of the housing or muffler may be, for example, between 8 mmand 3 mm, between 6 mm and 3 mm or 7 mm and 3 mm.

In certain embodiments, the noise output of the blower or blower housing(in dBA), the height of the blower or blower housing (in mm), the volumeof the housing (in cm³), the housing weight (in grams), the wallthickness of the housing or muffler (in mm) may be combined in variouscombinations to provide PAP systems with acceptable visual bulk,acceptable moment or torque, acceptable weight, acceptable noise output,acceptable noise and/or vibration damping or combinations thereof. Thehousing may be constructed or formed from a polymer such aspolypropylene, polyethylene, thermoplastics such as ABS (acylonitrilebutadiene styrene), nylon (including glass reinforced nylon).Alternatively the housing may be produced from a metal such as stainlesssteel. Alternatively, the housing may be constructed from a combinationof metal and polymer, for example metal over moulded with polymerportions.

The top face or portion of the housing (i.e., the region positionedfurthest from the patient when in use) may be weighted or includesecurement means to prevent vibration of the surface. Securement meansmay include ribs, thickened wall sections or additional weights added tothe region. Alternatively, the top portion of the blower housing may beconstructed of a material that has a high density. Combinations of thesesecurement means and higher density materials may also be used.

The blower housing may be separate or provide an isolated region wherethe PCB (printed circuit board) may be positioned. This may be toprevent the PCB from being in the air path of the patient.

In certain embodiments, the blower housing may be shaped to conform tothe patient's head or body. For example, the lower portion of the blowerhousing facing the patient's head may be curved or generally dome shapedto match the crown of a patient's head or to match the front portion ofa patient's head between the crown and the forehead of the patient. Inaddition, the blower housing may be curved or dome shaped to preventtransmission of vibration or drumming. Additionally, the blower housingmay have curved walls to protect the blower. The curvature of thehousing may be shaped to guard the blower, such that if the system wereto be dropped the curved surface would be hit first rather than a faceof the housing adjacent the blower (e.g., see FIG. 86). The housingportion may also include various baffles or ridges to muffle transmittedor emitted noise.

The blower housing may include location features such as cut outs orribs to position the blower and/or other elements within the blowerhousing.

The blower housing may be sealed. The blower housing may be hot platewelded, ultra sonically welded or otherwise sealed.

The blower housing may include a light to indicate the status of theblower. The light may indicate if the blower is on or off. The light mayindicate if the battery is charging, charged or running out. The lightmay indicate if there is a fault in the system. There may be multiplelights on the blower housing.

The blower housing may also include an on and off switch. The blowerhousing may also include a pressure ramp for the patient and/orclinician to adjust the pressure delivered by the system.

1.1.5.1 Certain Embodiments of a First Blower Housing

FIGS. 87-91 show certain embodiments of a blower housing 2000. Blowerhousing 2000 may be substantially circular when viewed from the top(e.g., see FIG. 90). Blower housing 2000 may include a first outletportion 2010 on its lower portion 2001 and a second outlet portion 2020on its upper portion 2002 (e.g., see FIG. 91). The outlet portions 2010and 2020, when positioned adjacent each other, may form an orifice forthe outlet of the blower to be placed in (e.g., see FIG. 90).

Upper portion 2002 may also include an inlet 2050. Inlet 2050 mayoptionally be positioned on lower portion 2001, or there may be multipleinlets 2050 on either or both of upper portion 2002 and lower portion2001 or any given surface.

The blower housing may be 20-50 mm high. The blower housing may be, forexample, 20-40 mm high. The blower housing may be, for example, 30-40 mmhigh. Other heights may also be used.

The blower housing may have, for example, a diameter of less than 100mm, a diameter of less than 90 mm, a diameter of less than 80 mm, or adiameter of less than 70 mm. Other diameters may also be used.

1.1.5.2 Certain Embodiments of a Second Blower Housing

FIGS. 92-99 show a certain embodiments of a blower housing 3000. Blowerhousing 3000 is substantially a semi-oval shape but may be other shapesso as to fit the blower within. Blower housing 3000 has a top portion3002 and a bottom or lower portion 3001. Lower portion 3001 has a curvedface or region 3005 (e.g., see FIG. 93) that may abut or rest on thepatient's crown or apex of the head in use. Alternatively, the blowerhousing may be adapted to abut or rest on the front portion of apatient's head between the crown and forehead regions.

Caps or clips 3030 may be placed around the top portion for securing thetop portion 3002 to the bottom portion 3001. Clips may latch or secureonto a face or surface on bottom portion 3001.

Bottom portion 3001 may also have an outlet 3010 for connection with anair delivery tube for supply a patient interface with breathable gas.Outlet 3010 may be substantially cylindrical, however other shapes arealso possible. Outlet 3010 may extend to the inner portion of the blowerhousing 3000 to a connection portion 3015 (e.g., see FIGS. 98 and 99).Connection portion 3015 may interface with a second tube and/or bloweroutlet for conveying the pressurized gas from the blower to the airdelivery tube.

Blower housing 3000 may also have inlets 3050, as shown in FIG. 97.Inlets 3050 may be substantially circular as shown, however, othershapes are also possible. Inlets 3050 may lead to lead-ins, snorkels,conduits or feeders 3055 (see FIG. 98) for delivering incoming air tothe inlet of the blower. Conduits 3055 may be as long as possible, orsuitable, so as to encourage laminar flow of the incoming gases, therebyreducing the noise and increasing the efficiency of the system. Circularor rounded inlets may encourage laminar air flow and thereby reducenoise and vibration. In this embodiment, the inlets are substantiallycylinder-shaped, however, other shapes are possible.

The blower housing may be, for example, 20-50 mm high, 20-40 mm high, or30-40 mm high. Other heights may also be used.

The blower housing may have, for example, a volume of approximately200-300 cm3. Other volumes may also be used.

1.1.5.3 Certain Embodiments of Third Blower Housing

FIGS. 100-106 show another embodiment of the present technology. Blowerhousing 4000 includes a top portion 4002 and a bottom portion 4001. Topportion 4002 further comprises a raised or elevated portion 4004 toaccommodate the blower. The blower may be positioned underneath orwithin elevated portion 4004. FIG. 101 shows elevated portion beinghigher than the rest of the top portion 4002.

Caps or clips 4030 are placed around the top portion for securing thetop portion 4002 to the bottom portion 4001. Clips may latch or secureonto a face or surface on bottom portion 4001.

Bottom portion 4001 may also have an outlet 4010 for connection with anair delivery tube for supply a patient interface with breathable gas.Outlet 4010 may be substantially cylindrical, however other shapes arealso possible. Outlet 4010 may extend to the inner portion of the blowerhousing 4000 to a connection p01 lion 4015. Connection portion 4015 mayinterface with a second tube and/or blower outlet for conveying thepressurized gas from the blower to the air delivery tube. Ribbed ornecked region 4016 (FIG. 106) may extend around a portion of thecircumference of the connection portion 4015 to enable retention betweenthe connection portion 4015 and a second tube or blower outlet.

Bottom portion may also comprise inlets 4050 (FIG. 105). Inlets 4050 maybe substantially rectangular shaped and may be positioned underneath orbelow the outlet 4010, although it should be appreciated that othershapes and locations for the outlets may be used. Inlets 4050 may extendwithin the inner portion of the blower housing 4000. A shelf or platform4060 may extend along a portion of the inner portion of the blowerhousing to encourage the incoming gases to develop laminar flow, therebyreducing the noise from the system.

1.1.5.4 Certain Embodiments of a Fourth Blower Housing

A blower housing according to certain embodiments is shown in FIGS.107-112.

Blower housing 5000 may have top portion 5002 and bottom portion 5001.Top portion 5002 may include clips or attachment means 5030 similar toprevious embodiments.

Bottom portion 5001 may also have an outlet 5010 for connection with anair delivery tube. Outlet 5010 may extend within the inner portion ofthe blower housing 5000 as a connecting portion 5015. Connecting portion5015 may connect to a second tube or outlet of the blower. Connectionportion 5015 may also include a rib or neck 5016 (FIG. 112) for ease andretention of attachment to a second tube or blower outlet.

Bottom portion 5001 may include inlets 5050 (FIG. 111). Inlets 5050 maybe substantially rectangular shaped and extend on either side of theoutlet 5010, although it should be appreciated that other shapes andlocations for the outlets may also be used. Inlets 5050 may extend tothe inner portion of the blower housing as ducts 5055, to allow incominggases to develop into laminar flow.

The inlets of the embodiments may be oriented in a direction normal tothe plane of the patient's face or extending upwards from the head ofthe patient. Inlets facing either the side of the patient's head or backof the patient's head may be avoided in situations where bed clothes orpillows are likely to or could possibly occlude or limit the air flowinto the blower or pump. However, other configurations may also be usedif desirable.

Also, the inlets may include redirection snorkels or lead-ins 5055 toredirect the air incoming air flow. Wherein the inlets are forwardfacing or extending in direction normal to the patient's face. The airflow may be redirected in a vertical orientation extending up and awayfrom the patient's head. Wherein inlet facing upwards, the configurationmay give rise to an additional advantage of a reduction in air flownoise perceived by the user or patient's ears.

In certain embodiments, the blower and the motor are decoupled, orsubstantially decoupled, from the headgear and patient's head. Thebetter the decoupling, the better the reduction of transmittedvibrational noise carried by the patient's skull or the headgear.Various forms of suspending the blower or the motor may be effective inachieving at least a portion of decoupling.

1.1.6 Certain Embodiments of a Blower Encapsulation

The blower may be decoupled from the interior of the housing by foam orsilicone suspension systems. Other suitable suspension systems may alsobe used. A silicone suspension system, according to certain embodiments,is depicted in FIGS. 113-117.

The blower may include a motor and a fan that are at least partiallyencapsulated in an elastic polymer jacket 6001. The jacket 6001 isadapted to absorb noise and vibration generated by the blower in use.The blower for use with this jacket may be a single stage centrifugalblower (not shown).

The jacket 6001 includes a first aperture 6002 positioned in the side ofthe jacket 6001 adapted to receive the tangential outlet of the blower.

The jacket may also include additional apertures on the top 6005 andbottom 6004 of the jacket 6001. Either of these apertures may receivethe inlet of the blower.

The jacket 6001 is adapted to be: connected or joined to upper portionof the housing in a manner to suspend the blower away from the bottomportion of the housing and the side wall of housing. This may decouple,or substantially decouple, the blower from the housing and receivetransmitted noise and vibration. The top aperture 6005 may be adapted toengage a respective upper mating portion of the housing and the bottomaperture 6004 may be adapted to receive the inlet for the blower.

There may be at least a 5 mm clearance gap between the inlet of blowerand inside surface of the lower portion of the housing. This clearancegap may be constructed and maintained by the jacket 6001 suspending theblower.

Further, the side walls of the jacket 6001 include a series of vibrationabsorbing protrusions 6003. In this embodiment, there are twelveprotrusions arranged around the circumference of the jacket 2001.However, other suitable numbers of protrusions may be provided. Theprotrusions limit sideways vibration of the blower and reducetransmitted vibration to the side walls of the housing.

The jacket may be made of relatively soft, elastic material such asmoulded silicone, but other materials may also be used for this purpose.

1.1.7 Certain Embodiments of a Blower within the Housing

FIGS. 118-122 illustrate an exemplary embodiment of a blower 7050 withina blower housing 7000, which blower housing acts as muffler in use. Theblower housing 7000 may include one or more aspects similar to thatshown in FIGS. 92-99 described above.

As illustrated, the blower housing 7000 includes a bottom portion 7001and a top portion 7002. The bottom portion 7001 includes a curvedsurface 7005 adapted to conform to the contours of the patient's head. Aseal may be provided between the top and bottom portions. Also, the topand bottom may be secured to one another by a cap, clips, ultrasonicwelding or combinations thereof.

The bottom portion 7001 includes an outlet 7010 adapted to connect to anair delivery tube. The outlet 7010 extends to an inner portion of theblower housing to a connection portion 7015. The connection portion 7015interfaces with a tube member 7020 communicated to the outlet of theblower 7050.

The bottom portion 7001 also includes two inlets 7051, one of which isshown in FIG. 120. As illustrated, each inlet 7051 leads to conduits orfeeders 7055 for delivering incoming air to the inlet of the blower.

The top portion 7002 includes a separating wall 7003 that provides anisolated region where the PCB 7006 (printed circuit board) may bepositioned, e.g., to prevent the PCB from being in the air path. Also, amass 7030 may be provided to the top portion 7002, e.g., to reducevibration and prevent “drumming”.

The top or bottom portion also includes a wire/cable exit (e.g.,opening) for electrical connections.

The blower 7050 is supported within the blower housing 7000 by one ormore foam portions (e.g., such as Accusorb™). The foam portions providevibration damping, noise absorption, blower location, volume filling orcombinations. However, such foam may be replaced with the siliconesuspension and/or encapsulation system discussed elsewhere.

As illustrated, a foam portion 7060(1) is provided to the top portion7002, a foam portion or foam circlip 7060(2) is provided along thebottom portion 7001, and a foam portion 7060(3) is provided along theinlets 7051. However, other foam portions may be provided.

The blower housing provides vibration isolation in use. For example, thefoam portions include compliant foam adapted to compress and hold theblower in place from top to bottom. The foam portions 7060(1) and7060(2) on the top and bottom portions limit the blower's verticalmovement. Also, the circlip or c-shaped configuration of the foamportion 7060(2) on the bottom portion limits the blower's sidewaysmovement. The tube member 7020 prevents back and forth movement of theblower. In addition, the mass 7030 on the top portion 7002 reduces thehousing's vibration.

The blower housing provides radiated sound reduction in use. Forexample, the volume of the blower housing (e.g., about 200-300 cm3(e.g., about 255 cm3) excluding the blower and PCB) functions as amuffler. The relatively long inlets 7051 reduce inlet noise. The foamportions act as sound absorbers and decouple the blower from the blowerhousing. The curved and domed exterior surfaces of the blower housingadd to structural rigidity. Also, the wall thickness of the blowerhousing (e.g., 3 mm wall section (in one-shot polymer) helps reducenoise. The mass 7030 on the top portion 7002 prevents “drumming”. Inaddition, the blower housing is fully sealed along the joint between thetop and bottom portions 7002, 7001 and along the wire/cable exit.

In the illustrated embodiment, the blower is inverted within the blowerhousing, i.e., the inlet to the blower is oriented downwardly as viewedin FIG. 118 for example. This arrangement reduces the overall height ofthe blower housing as it reduces or eliminates a clearance gap (e.g., ofabout 5 mm) on both sides of the blower. For example, a clearance gap isprovided on the inlet side of the blower to be able to suck enough air,while a clearance gap is provided on the PCB side of the blower toreduce heat transfer to the patient's head. Inverting the blower meansthat a clearance gap may be eliminated on the PCB side of the blower asthe gap is not needed to reduce heat transfer, and the blower can bepositioned against the top portion of the blower housing or have asmaller clearance, e.g., less than 5 mm. Heat transfer from the topportion of the blower housing is not significant as this side does notcome into direct contact with the patient's head.

The blower housing may be part of a wet air path, e.g., length of tubingconnecting the patient's mask and the blower housing may be relativelyshort such that air expelled by the patient (likely having a highhumidity level) may make the air path wet. It is noted that such backflow of air through the blower housing and blower is relatively minor asit may only occur for a relatively short time during peak exhalation.Accordingly, the components in the air path (e.g., foam portions 7060,tube member 7020, blower components (e.g., impeller, PCB, casing), topand bottom portions 7002, 7001, etc.) may be biocompatible or sealedfrom the airpath. For example, the foam portions within the blowerhousing may be adapted to be able to dry out, are biocompatible, and arenot likely to break up or disintegrate during use. The system mayinclude a first PCB mounted in the blower which provides computation andspeed control and a second PCB governs power regulation, etc., and bothPCBs are sealed against fluid ingress.

1.1.8 Certain Embodiments of a Flow Generator

FIGS. 137-148 depict certain embodiments of flow generator 8014 for usewith the PAP device or system. FIG. 137 depicts a top view of the flowgenerator 8014, wherein the housing 8015 is adapted to be joined to theextension portion 8003 of the headgear 8010. The housing 8015 includes afront facing portion 8018 and rear facing portion 8019. The front facingportion 8018 is adapted to be directed to the face of the patient, whenin use.

The housing 8015 may include a three piece construction of an upperhousing 8036, a middle housing 8034, and a lower housing 8035 asindicated in FIG. 145. The housing portions may be constructed of arelatively rigid material such as polymeric material, plastic and/ormetal. The three housing portions may be sealed with press fit seals8025. These seals are made of a TPE, TPU, rubber, silicone and/orsimilar soft elastic polymer.

The housing may be further improved for manufacturability purposes byreducing the number of housing portions. In further embodiments, it ispossible to reduce the housing portion to one or two.

In this embodiment, the side view profile of the housing 8015 is curvedor arcuate along the length of the housing as seen in FIGS. 138-139. Theradius of the lower surface 8027 of housing 8015 is between about100-400 mm. The preferred radius is about 172 mm. The aforementionedrange of radii is useful because this range suits the largest amount ofpatients and increases comfort.

Further the housing 8015 is also arcuate or curved along the width ofthe housing 8015 of the lower surface 8027. This can be seen in FIGS.141 and 142, wherein the radius of lower surface 8027 of the housing8015 along its width is between 100-1000 mm. The most preferred radiusof the width of the lower surface 8027 is 210 mm. This provides the sameor similar advantage to the radius along the length of the lower surface8027.

The upper surface 8021 of the housing 801.5 is also curved or arcuateand this improves the look and profile of the flow generator 8014 whenbeing worn. Additionally, it may prevent or limit the capacity of theinlet 8016 from accidental occlusion during use.

The flow generator may include a small blower 8029. The blower includesan upper housing portion 8022 and a lower housing portion 8023 joined bysnap locks or other fasteners. The blower may include a single stagecentrifugal blower including a relatively flat profiled electric motorand an impeller for pumping gas when rotated. The motor may be mountedin the upper portion 8022 of the blower 8029 to separate the heatgenerated by the motor and its electronics away from the head of thepatient. The lower portion includes a blower inlet 8032 and the impellerattached to the motor as shown in FIG. 144. The lower portion alsoincludes a blower outlet 8040 joined to a volute formed in the lowerportion 8023 of the blower 8029.

In certain embodiments, the blower 8029 has been surprisingly invertedin its orientation to minimize space taken up by the blower 8029 in thehousing. This is because less empty space is needed between the upperportion 8022 of the blower 8029 and the upper housing 8036 of the flowgenerator housing 8015 (i.e. when the inlet 8032 of the blower 8028 isdirected towards the patient), than in the reverse arrangement whereinthe blower inlet 8032 is directed away from the patient. This may be dueto the need for space to conduct heat away or dissipate heat generatedby the motor or blower.

Additionally, this inversion of the blower in the housing increases thevibration isolation from the headgear and the patient's head leading toa more comfortable PAP system or device when in use.

The blower 8029 may be mounted in the housing 8015 at an offset anglerelative to the plane 8031 defined the length of the housing 8015. Oneuseful offset angle 8030 is depicted in FIG. 140. In this embodiment,the offset angle 8030 may be up to 30° clockwise or anti-clockwise.However, the preferred offset angle is approximately 7° anti-clockwiserelative to the view of the right hand side shown in FIG. 140. Thisoffsetting the blower 8029 in the housing 8015 may allow for furthervibration and/or noise isolation relative to the headgear 8010 and/orpatient's head. Additionally, this offsetting the blower 8029 in thehousing 8015 may also allow for aesthetic improvements to case designand/or also minimization of the overall volume of the housing of theflow generator.

In this embodiment, a housing inlet 8016 is formed in the upper housingportion 8036. A single inlet hole may extend from the surface of thehousing into it in a downward direction. The inlet then turns 90° andempties into a sealed cavity of the housing 8015. Breathable gas isdelivered via inlet 8016 to the blower inlet 8032, wherein it ispressurized and delivered into the blower volute. From this location,the breathable gas exits the blower 8029 through blower outlet 8040,which in turn is connected to an outlet blower connector 8039. Thepressurized breathable gas then exits via the housing outlet 8017 on thefront facing portion 8018 of the housing 8015.

The housing inlet may include a filter receptacle 8020 for receiving aremovable air filter 8041 as shown in FIG. 145. This preventsparticulate matter from entering the blower 8029 or the patient'srespiratory system. The filter is usually made of a gas permeable lightweight mesh material specially cut to fit the receptacle 8020.

The inlet also includes a 90° bend. This further reduces noise exitingthe inlet 8016. Additionally, it directs the inlet 8016 in a directionaway from the patient's ears or face to reduce perceived noise, and alsoaway from the back of the head to reduce the risk of accidental blockageor occlusion when the patient is laying on pillow or similar item.

The sealed cavity within the housing 8015 forms a muffling body for theblower 8029 and further reduces noise and vibration transmission.

The housing outlet 8017 is fixed to the housing and is adapted forconnection to tubing to deliver the pressurized breathable gas to thepatient interface. The tubing and housing outlet 8017 may have astreamlined appearance and tubing continues along the patient's foreheadat a similar or the same angle to the radii used to determine the curvedlower housing surface 8027. The housing outlet 8017 connection to thetubing is generally a press-fit. The tubing may be constructed ofsilicone.

The blower outlet connector 8039 joins the housing outlet 8017 to theblower outlet 8040. Generally the connector 8039 is flexible and isadapted to seal around the outside of both the housing outlet 8017 andblower outlet 8040 at opposed ends of the connector.

Mounted in the housing 8015 is a printed circuit board control circuit8024. This control circuit may be encapsulated in a separate sub-housing803 7. The sub-housing 803 7 is adapted to prevent high humidity andfluid ingress into the control circuit 8024. The sub-housing may besealed from the main cavity of housing 8015.

The three portions of the housing 8034, 8035, 8036 may be fastenedtogether using screws. In this embodiment, the screw hole mounts, 8038depicts the location of the fastener placement. The screws mayalternatively be replaced with other type of secure fastening meansincluding gluing or ultrasonic welding etc.

In this embodiment, the interior wall of the housing 8015 is a coatingor lining 8026 with a noise deadening material deposited preferably byover-moulding processes. Other processes may be used. This lining 8026may be constructed of TPE, TPU, rubber or a silicone polymer or similarsoft elastic polymer. The lining 8026 may extend into the gaps betweenthe housing portions 8034, 8035, and 8036 and forms part of the seal forthe entire housing 8015. The lining 8026 may substantially increase thenoise reduction of the housing 8015 body and further increase thevibration and/or noise isolation of the blower 8029.

The blower 8029 may be held in position by foam suspension mechanism.The foam suspension mechanism is illustrated in FIGS. 147-148 as foammounting 8045. The foam mounting 8045 may act to further reduce noiseand vibration transmission and isolate the vibration of the blower 8029,when in use. The foam mounting 8045 may be constructed by moulding, diecutting or compression cutting techniques.

It is often desirable that the foam mounting 8045 be rigid enough tolimit the movement of blower 8029.

Typically, the foam mounting avoids occluding or covering portions ofthe housing inlet 8016 and/or the blower inlet 8032.

The foam mounting may be constructed of polyurethane foam. An example ofa foam for this purpose is Accusorb™ which has relatively good noiseabsorption characteristics. Accusorb™ is also known as Marathon MA32-180manufactured by Dunlop Foams which has a density of 31-32.5 kg/m³, tearresistance of 350 N/m minimum, tensile strength 100 kPa minimum,elongation 175% minimum, resilience 45% minimum and a compression set 5%minimum. Accusorb™ foam has a spring constant of about 600 N/m in itslinear zone of compression. Other possible mounting materials includesilicon foam, which has a spring constant of about 1,700-1,800 N/m inits linear zone of compression; Poron™ foam, which has a spring constantof about 9800 N/m in its linear zone of compression; VS Integra™ foamwhich has a spring constant of about 400 N/m in its linear zone ofcompression; and glass packaging foam which has a spring constant ofabout 1,100-1,200 N/m in its linear zone of compression. According tocertain embodiments the suspension mechanism, e.g. the foam mounting,may have a spring constant of about 400 N/m to about 1800 N/m, forexample about 600 N/m to about 1,200 N/m. According to certainembodiments, the suspension mechanism, e.g. the foam mounting, may havea maximum spring constant. According to certain embodiments, the maximumspring constant may be about 1,800 N/m. According to certainembodiments, the maximum spring constant may be about 9,800 N/m.

The flow generator 8014 may be adapted so that is able to function atvarious angles and orientations, unlike standard PAP devices which aredesigned to sit typically on a flat horizontal surfaces like bed sidetables. The embodied flow generator 8014 is adapted to work at anglesand to generate minimal noise in these alternate orientations. The foammounting 8045 provides support to the blower and supports and/or limitsvibration in unusual orientations and may prevent the blower vibrationand noise from being transmitted to the housing 8015 regardless of theangle of the blower or flow generator. The embodied flow generator 14may also be adapted to work upside down when not attached to theheadgear. This may allow the user or patient to simply place the flowgenerator 8014 on a bedside table and not even consider placing it inthe normal orientation because of the curved and concave lower surfaceof the housing portion.

Additionally, the convex upper surface of the housing prevents or limitsocclusion of the housing inlet 8016, even when the flow generator isinverted and the upper surface is directed down.

Preferably, the flow generator 8014 may also be adapted to be removedfrom the headgear 8010 and connected to an arm holster, chest holster orbelt holster for improved comfort and useability.

Referring to FIGS. 204A to 204M, a PAP device 100 according to certainembodiments is illustrated. The PAP device 100 comprises an upperhousing 101 and a lower housing 102 that form a housing for a blower, orflow generator, 105 that is configured to generate a flow of pressurizedbreathable gas. A filter cover 103 is provided on the upper housing 101to cover a filter which may be replaceably provided in the upper housing101. The filter cover 103 covers the filter inlet 131 on the housing fora blower, or flow generator, 105. The filter inlet 131 supports filtermaterial such that the edges of the filter material remain in position.The filter cover 103 also includes retention features or ribs adapted toprevent collapse of the filter during air flow therethrough. Airflow Fenters in the inlet 131 and down through an inlet tube 129 that directsair vertically downwards towards the lower housing 102. The inlet tube129 may have a cross-sectional area of approximately 150 mm2 toapproximately 300 mm2, or approximately 150 mm2 to approximately 250 mm2or approximately 200 mm2. The inlet tube 129 has a vertical openingtransversing from the filter inlet 131 towards the lower housing 102.The lower end of the inlet tube 129 terminates above the lower housing102 with a gap such as a 10-18 mm gap, for example a 13-15 mm gap, toallow air flow out of the lower end of the inlet tube 129 and into theinternal area of the housing 101, 102. The inlet tube 129 may comprisetwo vanes 133 at the lower end of the inlet tube 129 to prevent foreignobjects from being trapped within the inlet tube 129 and blocking theinlet tube 129. It should be appreciated that one or more vanes or otherstructures may be used to prevent blockage of the inlet tube 129. Oncethe air exits the lower end of the inlet tube it is dispersed in alldirections, or 360°, into the internal area of the housing and travelsup to the inlet 127 of the blower 105. In a certain embodiment a noiseabsorbing material 134 such as foam, for example Accusorb™ foam, isattached to the lower housing 102 below the inlet tube 129 to assist inreducing or muffling the noise generated from the inlet 131. The foam134 may have a thickness of about 3-8 mm, such as 4-6 mm, such as 4.5mm. It should be appreciated that other thicknesses of foam may be useddepending upon the size of the housing. In operation the inlet air flowis directed through the filter inlet 131, down the inlet tube 129 andinto contact with the foam 134 below the inlet tube 129 and is dispersedthroughout the internal cavity of the housing 101, 102. The directionand air flow path of the filter inlet 131 and inlet tube 129 reduce thenoise level transmitted from the inlet 131.

Referring to FIG. 204B, the blower 105 is provided in the housingbetween foam supports 106. An air inlet guide, or chimney, 109 may beprovided to the blower 105. For example, the chimney 109 may be overmoulded onto the blower 105. An inlet cage 107 is provided between thefoam support 106 and the chimney 109 to support the upper foam support106 in a fixed position above the blower 105 and establish a fixed inletpath to the blower chimney 109.

As shown in FIGS. 204A and 204B, an outlet tube having a muffler chamber104 is connected to the outlet of the blower 105 to reduce the noise ofthe airflow generated by the blower 105.

The foam supports 106 may be provided above and below the blower 105.The majority of the vibration of the blower 105 is on one axis, fromside to side. The blower 105 may be arranged such that it allowsmovement from side to side without touching, or substantially touching,structural features in the housing of the PAP device and so that theblower 105 is surrounded by air. The wires have been decoupled from theblower 105.

Vibration is absorbed for vibrations in the opposing axis, i.e. up anddown. The foam supports 106 are placed on the top and bottom of theblower 105. The foam supports 106 may be a low compression foam, forexample, 10-15%. The foam supports 106 may be formed of, for example,Accusorb™.

The upper housing 101 of the PAP device 100 is curved. To prevent thecurvature of the upper housing 101 from causing the foam supports 106 tobe more compressed at the sides, the foam supports 106 may includestraight sidles 119, as shown in FIGS. 204H and 204I. The upper foamsupport 106 may also be shaped to have a corresponding curvaturecorresponding to the curvature of the upper housing 101 of the PAPdevice 100.

The chimney 109 encourages more laminar flow into the blower 105. Thechimney 109 has a height of, for example, about 4 mm due to the limitedspace in the PAP device 100, although a taller chimney may improveacoustic performance. The diameter of the chimney is, for example, about16 mm to match the inlet hole, but larger diameters may be used, forexample, in a range of from 10-20 mm.

Referring to FIG. 204C, the blower includes a blower cover 111 having ablower inlet 127. An impeller is provided for radially accelerating theair flow. The impeller 112 may be as shown and described in, forexample, U.S. Patent Application Publication 2008/0304986 A1, the entirecontents of which are incorporated herein by reference.

The blower 105 also includes a bottom cover 118 which supports anelectromagnetic shield 108, see FIG. 204B, adapted to protect thepatient from electromagnetic fields emitted from the motor as describedin more detail below. In the assembled motor, the motor magnet 11 7 andbearings 116 are inserted into the circular space within the stator 114seen in FIG. 204C. The bearings 16 surround the motor shaft, and themotor shaft extends through the central opening to allow attachment ofthe impeller 112. The magnet may be as shown and described in, forexample, WO 2007/048205 A1 and WO 2007/048206 A1, the entire contents ofeach being incorporated herein by reference. The bearings 116 may be asshown and described in, for example, U.S. Patent Application Publication2008/0304986 A1.

The blower 105 further comprises a printed circuit board (PCB) 115 thatincludes circuitry configured to control the operation of the blower105. A stator 114 is provided on the PCB 115. The stator 114 may be asshown and described in, for example, WO 2007/048205 A1 and WO2007/048206 A1. An overmould 113 is provided between the stator 114 andthe impeller 112. Referring to FIG. 204B, the electromagnetic shield 108may be attached to the bottom cover 118 to assist with dampingvibration. The EMF shield 108 may have a circular flat shape with adiameter of, for example, 55 mm, and a thickness of, for example, 0.6mm. The EMF shield 108 may be made from magnetically conducted material,for example, stainless steel 430. The EMF shield 108 may be adhered tothe bottom cover 118 of the blower 105 by adhesive, for example, doublesided pressure sensitive adhesive.

As shown in FIGS. 204F, 204H and 204I, the inlet cage 107 may include aring 124 that is configured to be inserted around the chimney 109. Theinlet cage 107 may also include ribs 125 that are configured to bereceived in recesses 126 (FIG. 204E) in the chimney 109 to align theinlet cage 107 to support the upper foam support 106 in a fixed positionabove the blower 105 and establish the fixed inlet path to the chimney109. However, other means of retaining the inlet cage in position inrelation to the chimney 109 may be utilized, such as ribs on the chimney109 and slots or grooves on the inlet cage 107, an interference fit orsnap fit between the ring 124 and the chimney 109, clips, fasteners,etc. Furthermore, it should be appreciated that the inlet cage 107 maybe made in other forms or shapes and still provide a fixed inlet to theblower inlet via the chimney 109 and/or support the foam supports 106.

Referring to FIGS. 205A and 205B, the PAP device 100 may include a falsechamber 110 added to the bottom of the lower housing 102. The falsechamber 110 acts as a Helmholtz resonator and may have a volume of, forexample, 40 ml. The ratio between the volume of the false chamber 110and the volume of the housing 101, 102 of the PAP device 100 allowstuning of the noise generated by the PAP device 100. It should beappreciated that one of ordinary skill in the art that chambers havingdifferent volumes may be used. In addition, the false chamber 110 has adamping effect on the vibration by acting as a spring.

1.1.9 Certain Embodiments of Flow Generator Positioning

In certain embodiments depicted in FIGS. 130-148, a PAP device or systemincludes a flow generator 8015 that may be mounted or positioned on apatient's head using headgear 8010. The flow generator is positioned onthe patient's head near the crown or apex of the patient's head or on afront portion of the patient's head between the crown and the forehead.The PAP device or system may be adapted to deliver pressurizedbreathable gas to a patient. The PAP device may be used to treatrespiratory disease or insufficiency or alternately as a treatment forsleep apnea and or associated diseases. This PAP device or system isadapted to be light weight typically less than 500 grams and able to becarried or used when travelling (e.g. in planes, etc.) (most preferably,total weight of the system excluding power supply is 300-400 grams).

1.1.9.1 Certain Embodiments of the Headgear

FIGS. 130-136 depict certain embodiments of headgear that may be usedwith or as part of the aforementioned PAP device. FIG. 130 depicts theheadgear in a shape or configuration as it may be preferably worn ordonned by patient. The headgear 8010 includes an occipital ring 8001joined by stitching, gluing or some other known method at joininglocation 8006. The occipital ring 8001 is adapted to at least partiallyencompass or enclose or engage the occipital portion of the patient'shead. This may provide stable position for the headgear and allows forrelatively even distribution of the forces applied to the patient's headto maximize comfort.

The joining location 8006 may be positioned proximal to the base of thepatient's skull as that the stitching or gluing does not rub or becomeuncomfortable for patient during extended periods of use.

Preferably, the headgear 8010 includes two parallel (when positioned ona patient's head) upper straps 8002. These upper straps 8002 areoriented to be relatively horizontal, when worn, and extend from theoccipital ring 8001 towards the front of the headgear where thepatient's face is generally located.

The headgear 8010 may also include a further two relatively parallel(when positioned on a patient's head) lower straps 8005. These lowerstraps 8005 are positioned so that they also extend from the occipitalring 8001 towards the patient's face. The lower straps are generallyoriented in parallel to the respective upper straps 8002, when worn, butthe lower straps 8005 are adapted to extend from the lower portion ofring 8001 to the lower portion of the patient's face, while the upperstraps 8002 generally may extend to an upper portion of the patient'sface.

This configuration may generate a relatively stable headgear platform tomount portions of the PAP device which may include: flow generators,tubing, and/or patient interfaces (e.g. facial, nasal or mouth masks).

Positioned and joined on the extremities of the upper and lower straps8002, 8005 are preferably fasteners 8004. In this embodiment, thefasteners are hook and loop fasteners (including Velcro™ tabs) adaptedto engage slots (not shown) on a patient interface (not shown). The hookand loop fasteners tabs may be inserted through the said respectiveslots and used the engage and secure the patient interface against thepatient's face.

The patient interface may be adapted to cover a portion of the patient'sface and delivers pressurized breathable gas to the patient'srespiratory system.

The headgear 8010 depicted in this embodiment may include an extensionportion 8003 covering at least a section of the top of the patient'shead. The extension 8003 may cover a portion of the patient's crown. Inthis embodiment, the extension is adapted to be a section of theheadgear 8010 for mounting a flow generator 8014 (such the flowgenerator 8014 depicted in FIGS. 137-148).

The extension 8003 may be shaped to cover the entire lower surface ofthe flow generator 8014, when the flow generator 8014 is mounted.Additionally extension 8003 may include on its upper strap a typemounting fastener (not shown). It should be appreciated that thefasteners may include hook and loop fasteners, glues, and/or clips.

The extension portion 8003 includes an electromagnetic force (EMF)shield 8008 as depicted in FIG. 134. In this embodiment, the EMF shield8008 is a relatively small piece of sheet metal generally cut into atrapezium shape with a rounded bottom and rounded corners. However, theEMF shield may be made in other shapes. In certain aspects, the EMFshield may be in a shape that corresponds to the shape of the lowersurface of the flow generator assembly. This EMF shield 8008 is adaptedto be inserted or encapsulated within the headgear. The EMF shield 8008may be positioned between the motor and electronics of the flowgenerator 8014 and the patient's head, this may prevent, limit ormitigate the potential for EMF or ionizing radiation adversely affectingthe patient, when using the PAP device for extended periods of time, orduring repeated uses.

Preferably the extension portion 8003 may only need to be connected tooccipital ring 8001 in this embodiment and does not require more strapsor head cover. This improves the useability and/or comfort of using thePAP device.

1.1.9.2 Certain Embodiments of the EMF Shield

The EMF shield 8008 may cover and block the path of EMF radiationemitting from the motor controls and flow generator electronics. The EMFshield may also function as a heat sink or a heat diverter. In thisembodiment, the EMF shield 8008 may divert heat emitting from the flowgenerator 8014 away from the patient's head preventing burning ordiscomfort, when the flow generator is operating for extended timeperiods. In certain embodiments, the EMF shield covers 100% of the areabetween the flow generator 8014 and the patient's head, but this may bereduced to 50% to reduce the bulk, size and/or weight. In certainembodiments, the EMF shield may cover between 100 to 50%, 90 to 40%, or95% to 50% of the area between the flow generator and the patient'shead. The EMF shield 8008 may be flexible or rigid, however in thisembodiment the EMF shielding is relatively rigid to prevent unnecessarymovement of the flow generator 8014.

Generally, EMF or electromagnetic shielding is the process of limitingthe penetration of electromagnetic fields into a space, by blocking themwith a barrier made of conductive material. Typically it is applied toenclosures, separating electrical devices from the ‘outside world’, andto cables, separating wires from the environment the cable runs through.Electromagnetic shielding used to block radio frequency electromagneticradiation is also known as RF shielding.

The shielding may reduce the coupling of radio waves, electromagneticfields and electrostatic fields, though not static or low-frequencymagnetic fields (a conductive enclosure used to block electrostaticfields is also known as a Faraday cage). The amount of reduction dependsvery much upon the material used, its thickness, the size of theshielded volume and the frequency of the fields of interest and thesize, shape and orientation of apertures in a shield to an incidentelectromagnetic field.

Typical materials used for electromagnetic shielding include sheetmetal, punched sheet metal and or metal foam. Any holes in the shield ormesh must be significantly smaller than the wavelength of the radiationthat is being kept in or out, or the enclosure will not effectivelyapproximate an unbroken conducting surface.

Another commonly used shielding method, especially with electronic goodshoused in plastic enclosures, is to coat the inside of the enclosurewith a metallic ink or similar material. The ink consists of a carriermaterial loaded with a suitable metal, typically copper or nickel, inthe form of very small particulates. It is sprayed on to the enclosureand, once dry, produces a continuous conductive layer of metal, whichcan be electrically connected to the chassis ground of the equipment,thus providing effective shielding

Electromagnetic radiation consists of coupled electric and magneticfields. The electric field produces forces on the charge carriers (i.e.,electrons) within the conductor. As soon as an electric field is appliedto the surface of an ideal conductor, it induces a current that causesdisplacement of charge inside the conductor that cancels the appliedfield inside, at which point the current stops.

Similarly, varying magnetic fields generate eddy currents that act tocancel the applied magnetic field. The conductor does not respond tostatic magnetic fields unless the conductor is moving relative to themagnetic field. The result is that electromagnetic radiation isreflected from the surface of the conductor: internal fields stayinside, and external fields stay outside.

Several factors serve to limit the shielding capability of real RFshields. One is that, due to the electrical resistance of the conductor,the excited field does not completely cancel the incident field. Also,most conductors exhibit a ferromagnetic response to low-frequencymagnetic fields, so that such fields are not fully attenuated by theconductor. Any holes in the shield force current to flow around them, sothat fields passing through the holes do not excite opposingelectromagnetic fields. These effects reduce the ‘field-reflectingcapability of the shield.

Equipment sometimes requires isolation from external magnetic fields.For static or slowly varying magnetic fields (below about 100 kHz) theFaraday shielding described above is ineffective. There exists a limitedpossibility of passively isolating a volume magnetically by usingshields made of high magnetic permeability metal alloys such asPermalloy™. These materials may not typically block the magnetic field,as with electric shielding, but rather draw the field into themselves,providing a path for the magnetic field lines around the shieldedvolume. One shape for magnetic shields may be a closed container. Theeffectiveness of this type of shielding decreases with the material'spermeability, which generally drops off at both very low magnetic fieldstrengths, and also at high field strengths where the material becomessaturated. So to achieve low residual fields, magnetic shields oftenconsist of several enclosures one inside the other, each of whichsuccessively may reduce the field inside it.

1.1.9.3 Certain Embodiments of the Rigidiser

In certain embodiments, the headgear 8010 may also include at least onerigidiser 8007 as shown in FIG. 133. The rigidiser 8004 may be arelatively flat piece of resilient and nonextensible material that maybe constructed of plastic and/or metal. The rigidiser may be bent intothe configurations shown in the FIGS. The rigidiser also may be adaptedto be more rigid than the flexible straps of the headgear 8010. Incertain embodiments, the rigidiser 8007 may serve several functions. Thefirst function may be to provide three dimensional structure or shape tothe headgear 8010, when the occipital ring 8001 is joined. The rigidisersupports and maintains the shape of the occipital ring 8001 despite thefact that the headgear may be constructed of otherwise fairly flexiblematerial including foams and fabrics. In this embodiment, the rigidiser8007 extends along the upper straps 8002 to assist in retaining theirshape.

The rigidiser 8007 also may serve a second function to redistribute theforces applied to the patient's head by loading of the flow generator8014 and the patient interface (not shown).

Additionally, the rigidiser 8007 may assist in the positioning of theflow generator 8014 on the crown of the patient's head. In thisembodiment, an arm of the rigidiser 8007 extends into the extensionportion 8003. This secures the extension portion 8003 and preventsand/or limits unnecessary movement or motion of the flow generator 8014relative to the patient's head. The rigidiser may also be affixed orjoined to the EMF shielding 8008 to better secure the arrangement inplace.

An appropriate cross-section of a portion of the straps in the headgear8010 is depicted in FIG. 136. FIG. 136 shows two layers of fabric 8011ultrasonically welded and cut encapsulating a layer of polyurethane foam8009 between them. The edges of the strap have been ultrasonicallywelded and cut resulting in a rounded edge to prevent irritation to thepatient's skin. The rigidiser 8007 may be inserted into strap prior toultrasonic welding and be encapsulated within the strap or headgear8010.

FIG. 132 depicts a cross sectional view of the extension portion 8003including two layers of fabric 8011 ultrasonically cut and welded aroundlayers of foam 8009. Within the layers of fabric 8011 are encapsulatedthe EMF shield 8008 and a portion of the rigidiser 8007. Additionally,foam and/or fasteners may be attached to the upper surface of theextension portion 8003.

In this embodiment, as a result of the rigidiser 8007 and EMF shield8008, the preferred flow generator may mounted on the crown of thepatient's head or at the front of a patient's head without the need of afull helmet or covering that covers a majority of the patient's head. Inthis embodiment, the flow generator may be affixed to the headgear by asingle attachment point to the extension portion 8003 and the extensionportion 8003 is joined to the headgear 8010 by another single attachmentpoint. This may improve the overall look of the PAP device, increasecomfort and useability, or combinations thereof, of the PAPdevice/system.

1.1.9.4 Certain Embodiments of the Flow Generator Securement

The headgear and/or flow generator arrangement may include a mechanismto allow repositioning and realignment of the flow generator withrespect to the headgear and/or the patient. In one form the mechanismabsorbs vibration emitted from the flow generator. In one form therepositioning mechanism is structured to allow engagement anddisengagement of the flow generator from the headgear. In another form,the repositioning mechanism is structured to secure and stabilize theflow generator once it is engaged with the headgear. In another form,the repositioning mechanism is structured to absorb vibration from theflow generator. In another form, the repositioning mechanism isstructured to reduce the visual bulk of the system when in use by apatient or streamline the appearance of the system when in use by thepatient. In certain embodiments, the headgear and/or flow generatorarrangement may include a mechanism to allow repositioning andrealignment of the flow generator with respect to the headgear and/orthe patient that may absorb vibration emitted from the flow generator,is structured to allow engagement and disengagement of the flowgenerator from the headgear, is structured to secure and stabilize theflow generator once it is engaged with the headgear, is structured toabsorb vibration from the flow generator, is structured to reduce thevisual bulk of the system when in use by a patient, streamline theappearance of the system when in use by the patient or combinationsthereof.

FIGS. 149-152 show alternative methods of ensuring the flow generator issecured in position on the headgear 8010. Cup or sling or cradle 8110may capture or cover a portion of the flow generator 8014 to reduce thepossibility of the flow generator 8014 displacing from the extensionportion 8003 of headgear 8010. The cup 8110 may capture a rear portion8141 and/or side portions 8142 of flow generator 8014. This may alsoassist the patient with aligning flow generator 8014 on extensionportion 8003 of headgear 8010 if the flow generator is able to beremoved from the headgear.

Cup 8110 may be integral to or formed with occipital ring 8001. Cup 8110may be selectively attachable to the occipital ring 8001. Alternatively,cup 8110 may be attachable to a strap or other portion's of headgear8010.

Cup 8110 may be flexible so that it may conform to the shape of the rearportion 8141 and side or back portions 8142 of the flow generator 8014when in position. In addition, the cup 8110 may be flexible to absorbvibration and noise from the flow generator 8014. For example, cup 8110may be made from fabric, polymer, foam or other flexible material orcombinations thereof. Alternatively, cup 8110 may be rigid or semi-rigidso that the flow generator may abut or align to the cup.

Raised portions 8150 may be positioned adjacent extension portion 8003so as to absorb noise and vibration from the flow generator 8014, toassist in alignment of the flow generator 8014 when placing it onextension portion 8003, and to secure the flow generator in positiononce it is positioned on extension portion 8003 so as to prevent it frommoving from its intended position on headgear 8010. There may be one ormore raised portions 8150. There may be two raised portions 8150 so asto secure the flow generator from at least two sides. There may be morethan two raised portions 8150, such as three raised portions, to greatersecure the flow generator. In certain embodiments, there may be 1, 2, 3,4, 5, 6, 7, 8, or more raised portions.

Raised portions 8150 may be positioned on and/or in the occipital ring8001. Raised portions 8150 may have a thickness that is greater than atleast a portion of the occipital ring 8001. The raised portions 8150 maybe thicker than the entire occipital ring.

Raised portions 8150 may be constructed from a flexible and/orresiliently deformable material such as foam, fabric, polymer, gel, etc.Raised portions may be formed or otherwise attached to the headgear8010.

Raised portions 8150 may include ribs 815.1. In certain embodiments, theribs may reduce visual bulk. Ribs may also assist in maintaining thedesired shape of the headgear. Ribs may also strengthen the headgear inthis region to enable better securement of the flow generator 8014.

The flow generator 8014 may have securement means attached on itsunderside, or at least a portion of the face that abuts the extensionportion 8003. For example, the flow generator 8014 may include hookmaterial on the face that touches extension portion 8003. Extensionportion 8003 may be made from loop material so as to engage with thehook material of the securement means attached to the face of the flowgenerator 8014. Alternative securement means are possible such as pushfit pins, slidably engageable hooks and loops, buttons, tacky materialsetc.

Securement means may be a hook and loop material as this may furtherabsorb vibration from the flow generator.

1.1.9.5 Certain Embodiments of Flow Generator Position Adjustment

FIGS. 153-155 show an alignment feature for headgear 8010. Extensionportion 8003 may include strap 8161 to connect extension portion ‘8003to a portion of a patient interface 8100. This may enable betteralignment and securement of the extension portion 8003 in relation tothe patient interface 8100.

Strap 8161 may further include a ruler or measurement guide 8160 toindicate the tightness or length of strap 8161. The measurement guide8160 may have any reasonable indication of adjustment such as numbers,letters and/or pictures.

This may assist the patient in adjusting the length or tightness of thestrap 8161 to the same degree each time they set or adjust the headgear.

1.1.9.6 Flow Generator to Patient Interface Tubing

In a preferred embodiment of the present technology as depicted in FIGS.156-160. A PAP system 8501 includes a flow generator 8500 preferablymounted or positioned on or near or in front of the crown or apex of apatient's head using headgear 8502. Preferably, the PAP system isadapted to deliver pressurized breathable gas to a patient. The PAPsystem may be used to treat respiratory disease or insufficiency oralternately as a treatment for sleep apnea and or associated diseases.This PAP system is adapted to be light weight, typically less than 500grams, and able to be carried or used when travelling (e.g. when thepatient is travelling such as on a plane, etc.).

The PAP system 8501 includes a mask 8503 for the delivering pressurizedbreathable gas to the airways of the patient 8505. In this embodiment,the mask 8503 is a nasal mask, but other ventilation or respiratorymasks may be used.

The mask 8503 is connected to the flow generator 8500 by a first sectionof tubing 8504 which in turn connects to a second portion of tubing8507. The second portion of tubing may be substituted with differentlengths of tubing to accommodate different head sizes of variouspatients.

The mask may include a diffuse vent 8506 to allow the exhalation ofgases from the mask and patient. In this embodiment, the vent may bemounted in the center of the surface of mask directed away from thepatient.

In this embodiment, the mask 8503 includes a relatively soft cushion,which may be constructed of silicone and a more rigid and resilientframe body 8509. The frame body 8509 supports at least a portion of thetubing connecting the mask to the flow generator.

The headgear 8502 may secure the mask and flow generator with hook andloop (Velcro™) fasteners. Some of these fasteners are illustrated inFIG. 156 as 8510. The headgear 8502 includes a plurality of straps. Theflow generator 8500 is positioned on or in front of the crown of thepatient's head. On the straps extending away from the flow generator,padding 8508 has been added to reduce visual impact and size of the flowgenerator on a patient's head. Additionally, the padding may limit orreduce vibration, shock and/or noise transmission. The padding 8508 istypically constructed of foam inserted or encapsulated within theheadgear 8502.

The flow generator 8500 may be selectively attached to the headgear 8502using a cradle 8550. The cradle may comprise a base wall which engagesthe underside of the flow generator 8500 and a side wall.

In this embodiment, the base wall engages the entire underside of theflow generator but different sizing may be possible. The base wall maybe larger than the surface area of the underside of the flow generatorto allow the flow generator to be mounted at multiple sites.Specifically, the flow generator may be mounted further forward or backrelative to the patient and this may allow the flow generator to bemounted on the crown of the patient's head regardless of the differentanthrometric sizing of the patient.

Hook and loop fasteners (Velcro™) may be used to releasably connect tothe flow generator 8500 onto the cradle 8550. An advantage with usinghook and loop fasteners may be that the connection is softer and moreflexible than other attachment means. The fasteners may allow for theconnection between the cradle and flow generator to provide a dampingmeans which may limit or reduce transmitted noise or vibration.

The side wall of the cradle 8550 may at least partially cover or extendalong the side wall of the flow generator, when it is mounted in thecradle. The cradle may include two side walls to engage respective sidewalls of the flow generator. This allows for the flow generator to bepositioned so that the outlet of the flow generator is facing forward(e.g. generally towards the face of the patient). Additionally, the sidewalls are adapted to engage the side walls of the flow generator in thevarious mounting sites or positions.

The side walls of the cradle may be joined with an elastic strap orextendible side wall adapted to extend along the back or rear of theflow generator, when mounted. The elastic strap may be adapted to expandand contract depending on the various positioning of the flow generator,when mounted in the cradle. The elastic strap is adapted to move forwardand engage the back of the flow generator, even when the flow generatoris mounted in a forward position (e.g. closer to the patient's face). Insituation where the flow generator is directed or positioned more to therear, the elastic strap expands to accommodate the new position. Thispermits various positioning of the flow generator on the patient's head.

Additionally, the cradle is generally constructed of soft fabric. Thesoft fabric may also give rise to the cradle functioning as a vibrationdamping means to reduce or limit the transmitted noise and/or vibrationof the flow generator.

Referring to FIGS. 53A to 55B, a headworn PAP system according tocertain embodiments is illustrated. As shown in the figures, the flowgenerator 8500 may be located on the front of the head of the patient8505 between the crown and the forehead. This position of the flowgenerator on the front of the head may be more comfortable as the neckmuscles at the back of the neck are bigger and stronger and are able tosupport the weight and prevent the head dropping forward better than thesmaller muscles at the front of the neck. In tests conducted on usershaving varying forehead heights and head circumferences, the mostcomfortable position for the flow generator 8500 on the head, asmeasured on the forehead from the flow generator outlet to the top ofthe mask frame was identified as between about 30 mm and 60 mm. Thisrepresents an adjustment range of about 30 mm. The PAP system may havean adjustment range of 30 mm by providing the second section of tubing8507 with a length of about 30 mm.

FIG. 158 illustrates a cross-sectional view of the flow generator 8500.The flow generator 8500 includes a blower 8520. The blower 8520 includesa blower outlet 8526 which is in turn connected to the housing outlet8521. The blower motor is positioned with the inlet of the blowerdirected away from the patient towards the top of the flow generator.The housing portions may be secured and held together using screw mounts8527.

The interior of housing of the flow generator 8500 is overmoulded with arelatively soft polymeric substance 8524 to absorb noise and/orvibration. The overmoulding extends into the housing cavity of the flowgenerator 8500 to form mounting brackets 8525 to hold and secure theblower motor 8520 in place. The mounting brackets 8525 may formprotrusions extending upwardly from the base of the interior of the flowgenerator 8500. These protrusions are adapted to form a cradle for theblower motor at some position below the blower motor 8520. The housingcavity in the flow generator may be filled with a compressible foammaterial that dampens and/or reduces the vibration transmitted by theblower motor, when in use. When the foam is compressed or deterioratesthe blower motor may eventually rest on the ends of the protrusions. Theprotrusions may also function to limit or reduce vibration by a dampingmechanism. Four protrusions may extend into the cavity of the flowgenerator, but the number of protrusions may be increased to improvestability of the blower motor. The protrusions may be shaped and/oradapted to receive the blower motor and mate with the external shape ofblower motor. The height of the protrusions may be less than the heightof the blower motor suspension above the base of the interior of theflow generator.

The flow generator includes a housing inlet with an inlet cover 8522.Additionally the inlet cover 8522 may function as a muffler body.

The cavities of the flow generator may be filled with foam to suspendthe blower and/or other components and to suppress noise and/orvibration.

A hardware control circuit 8523 is vertically mounted at the back of thehousing. The control circuit is driven by a 12 v DC power supply (asshown in FIG. 160). The control circuit 8523 may be capable of beingpreset to a certain factory set motor speed to produce a predeterminedlevel of pressure support. For example, the pressure support may bepre-set to 8, 10, or 12 cm H20 of pressure. Alternatively the device mayinclude a plurality of preset pressure level settings. Each pressuresetting adjusting the motor speed to provide the required pressuresetting. Preferably the pressure level may be adjustable using a specialtool, similar to a screwdriver, such that a health care provider orclinician is required to set the prescribed pressure level to preventself-medication of the pressure level. The device may be turned on withpower is supplied and turned off when the power is withdrawn such thatno on and off switch is required. However, an on and off switch may beprovided to control the operation of the device.

The control circuit may also include a flight mode switch. When flightmode is activated or engaged, the control circuit operates the blower ata predetermined pressure setting appropriate for therapy treatment whichhas been adjusted for an external ambient air pressure appropriate forabout 6000 ft. This adjusts the control circuit to deliver the requiredtherapeutic pressures while the patient is using the system in thenormal cabin pressure of pressurized passenger aircraft. Specifically,the blower is operated by the control circuit at slightly increasedspeed to compensate for the lower air pressure in the cabin than whenthe patient is at ground level. In certain embodiments, 6000 ft isexemplary and other pressure settings may be selected or predeterminedto adjust for an external ambient air pressure at elevated heights.

The flight mode switch may be activated either: manually by a patientactivating a mechanical electrical switch mounted on the housing of theflow generator; or automatically by sensors mounted on the controlcircuit that detect the ambient air pressure external to the pressurizedsystem.

In this embodiment, the power supply connection 8530 has been optimizedand adapted for use with most DC power supplies or rectified currents.For example a wide DC operating range of 10 to 20 volts may be utilized.In certain applications between 10.2-18.7 volts may be used. FIG. 160demonstrates some of the accessories that may be used to power the PAPsystem. For marine, automobile or aircraft travel, it may be suitable touse a cigarette lighter convertor to connect to a supply power. At home,a universal mains adaptor could be used to supply power. For occasionalor short trip travel, single use or rechargeable batteries may beconnected to the system. The socket 8517 for the power cord 8515 isdesigned to allow easy removal if the tension on the cord is too high toprevent any risk of strangulation.

Additionally, the present embodiment could be adapted for the treatmentof asthma. The PAP system is light and portable and can be easilycarried by patients due to its light weight and lack of bulk. Thedelivery of 8-12 cm H20 may be suitable to treat asthma and prevent orlimit the severity of acute asthma attacks.

1.1.10 Certain Embodiments of the Nasal Mask System

Certain exemplary embodiments may be directed towards a nasal masksystem that is easy and quick to fit (e.g., with little or noadjustment), enable reduced strap tension, is manufacturable in highvolumes, provides high consumer appeal, provides comfort and seal,provides reliable quality, fits a suitable majority of the population orcombinations thereof.

As described in greater detail herein, the nasal mask system includes aframe, a sealing arrangement (e.g., a cushion) provided to the frame andadapted to form a seal with the patient's nose, and an elbow, e.g.,provided to lthe sealing arrangement, adapted to be connected to an airdelivery tube that delivers breathable gas to the patient.

A swivel ring may be optionally provided to couple the elbow to thesealing arrangement. Headgear may be removably attached to the frame tomaintain the nasal mask system in a desired adjusted position on thepatient's face. The nasal mask system is intended for use in positivepressure therapy for users with Obstructive Sleep Apnea (OSA) and/orother respiratory disorders.

While the illustrated examples below describe use of a nasal interfacetype, however, these non limiting examples may be adapted for use withother suitable interface types, e.g., full-face interface, nasal prongs,etc.

1.1.10.1 Certain Embodiments of the Patient Interface

Certain embodiments may be adapted to work, or to be used, with a lightweight travel PAP device or system. The PAP system may be mounted on thebody of the patient. The placement of the flow generator forming part ofthe PAP system is on or in front of the crown of the patient's head.However, other placements may also be used.

The first embodiment relates to patient interfaces including masks forthe delivery of pressurized breathable gas to patient and for use withtravel PAP devices and/or systems.

1.1.10.2 Certain Embodiments of the Patient Interface SealingArrangement

The sealing arrangement 9040 is structured to interface with the frame9020 and form a seal with the patient's nose in use. The sealingarrangement 9040 may provide a nasal interface adapted to engage thepatient's face generally along nasal bridge, cheek, and upper lipregions of the patient's face. However, other interfaces are possible,e.g., full-face. The sealing arrangement provides a compliantarrangement adapted to seal relatively quickly and maintain seal in use.The sealing arrangement may be structured to seal with or without airpressure.

1.1.10.3 Certain Embodiments of the Silicone Cushion

FIGS. 161-168 illustrate certain embodiments. In these figures, thesealing arrangement 9040 includes a cushion 9042 constructed of asubstantially flexible material including but not limited to silicone.TPE, gel, other suitable materials or combinations thereof. The cushion9042 defines a breathing chamber or cavity adapted to receive thepatient's nose and provide air communication to the patient.

The face-contacting side of the cushion 9042 may include a dual-wallconfiguration wherein the cushion includes an undercushion and amembrane that at least partially covers the undercushion. The membranemay softer and less stiff than the undercushion and provides a sealagainst the patient's face in use. The undercushion may be structured tosupport the membrane and prevent collapse of the membrane when the nasalmask system is attached and tightened using the headgear. Theundercushion may only be provided in selected regions of the masksystem, e.g., along the cheek regions, or not at all. Also, the cushionmay be frosted, e.g., for easy fit and comfort, and/or tinted.

The cushion includes a sickle-shape or question-mark configuration witha base portion and an upper portion that is radially offset towards theoutside of the base portion, e.g., to reduce size and perceived bulk,minimize dead space within the breathing chamber, and/or add moreflexibility to the undercushion and membrane in use. Such cross-sectionmay be provided around the entire perimeter of the cushion or may onlybe provided in selected regions of the cushion. The“question-mark”-shaped cross-section in the upper lip region may includeless curvature, e.g., to avoid overhang of the cushion into thepatient's mouth and prevent nostril occlusion.

The gap or spacing between the membrane and undercushion may beadjusted, e.g., to reduce wrinkling and possibility of leaks, when inuse. For example, the gap may be relatively small so that the membraneclosely follows the geometry of the undercushion. The cushion may bemoulded so that the gap is larger, but the membrane is preloaded tohinge closer to the undercushion after moulding. A bellows may be alsoprovided or moulded with the membrane to bias the membrane closer to theundercushion.

The non-face-contacting or frame side of the cushion 9042 includes oneor more interfacing structures adapted to interface or otherwiseremovably connect to the frame 9020. In the illustrated example, thecushion 9042 includes one or more elongated and spaced protrusions 9050,e.g., along the sides and bottom thereof adapted to engage or interlockwith respective openings 9027 along the side wall 9026 of the frame9020. As shown in FIGS. 176 to 178, such arrangement provides positivereinforcement that the connection has been established as the user canvisually see the connection and optionally a proper connection mayresult in an audible clicking noise.

For example, a possible arrangement for connecting the cushion 9042 tothe frame 9020 is disclosed in U.S. Pat. No. 7,000,614.

The non-face-contacting side of the cushion 9042 also includes anopening 9075 adapted to receive or otherwise communicate with the elbow9070 as described herein.

As illustrated, the face-contacting side of the cushion (i.e. includingthe membrane and undercushion) may be co-moulded with or formedseparately and attached to the non-face-contacting side of the cushion(i.e., defining the opening 9075 and breathing chamber). The facecontacting side of the cushion and the non-face-contacting side of thecushion may be formed as a single component. This single component maybe made from a flexible sealing material that is sufficientlybiocompatible when in contact with patient's skin, including but notlimited to silicone.

In this embodiment, the cushion defines an interior cavity. The cavityis connected to and in air communication with an inlet tube. The inlettube may be adapted to be integrally moulded with the cushion in onepiece. Additionally, the arcuate bridge may be attached or integrallymoulded to the frame and forehead support regions.

1.1.10.4 Certain Embodiments of the Inlet Tube

The inlet tube 9070 includes a first end 9072 and a second end 9074,(e.g., see FIGS. 161-167). The first end 9072 provides an interfacingstructure structured to interface or otherwise attach to the sealingarrangement 9040 or the cushion. The second end 9074 is adapted to beconnected to an air delivery tube or intermediate tube. The first end isapproximately angled about 90° with respect to the second portion and isto be positioned on the patient, when worn, in a substantially verticalorientation (i.e. upwardly along the patient's face to their forehead).However, the first and second end of the inlet tube may have othersuitable angles with respect to one another, e.g., 0°, between about 70°and 90°, between about 90° and 120°, between about 75° and 85°, etc.

The inlet tube 9070 may be to be mounted between the two arms 9032which, when in use, extend and support each side of the inlet tube 9070of the patient interface.

The inlet tube 9070 may be adapted to be clipped and retained by acurved or accurate bridge 9038 of the forehead support 9030. The bridgeis adapted to receive and mate with the inlet tube 9070 and applycompression force to the inlet tube. The compression force may beapplied to either side of the inlet tube and adapted to provide aclamping force around the inlet tube. This force may be sufficient toretain and secure the inlet tube, however, not enough to collapse orocclude the inlet tube. The inner walls of the bridge 9038 grasp theouter wall of the inlet tube 9070 to hole and retain it in positionwithout occluding the cavity for delivering pressurized breathable gas.Further the bridge may extend along the side walls of the inlet tube andjoin on the front (i.e. the side facing away from the patient) of theinlet tube.

The inlet tube 9070 may include D-shaped cross sectional profile whenthe cross section is taken across its width. The bridge 9038 may coverand engage the long side of the D-shape of the inlet tube 9070. Thebridge 9038 wraps around and engages the corners of the D-shape of theinlet tube.

The clip mechanism operating between the bridge and the inlet tube maybe selectively releasably by the patient. This may aid in cleaning thepatient interface.

The D-shape of the inlet tube may reduce its visual profile and/orimpact when the patient interface is worn, as well as the shape may alsoreduce transmitted noise and/or vibration. The D-shape may alsostrengthen the inlet tube 9070 and limit the likelihood of accidentalpartial or full occlusion. The intermediate or connector tube may besubstantially D-shape in various regions to allow similar advantages. Itshould be appreciated that other cross sectional shaped maybe used.

The bridge 9038 may be mounted near to or proximal to second end 9074 ofthe inlet tube 9070. This may allow the relatively softer portions ofthe patient interface to be reliably secured and prevent or limitunintended movement of the cushion and/or inlet tube by joining at theextremities of the patient interface.

The inlet tube 9070 may be made by co-moulding it with the rest of thecushion assembly. Additionally, the inlet tube 9070 may be constructedof silicone.

The length of the inlet tube may be, for example, between 40-65 mm. Thelength of the inlet tube may be, for example, approximately 55 mm.

1.1.10.5 Certain Embodiments of the Frame

As shown in FIGS. 169-179, the frame 9020 (also referred to anexoskeleton or skeleton) is structured to maintain or otherwise supportthe sealing arrangement 9040 (and also the elbow 9070) in an operativeposition with respect to the patient's face. In addition, the frame 9020is structured to attach headgear to the nasal mask system.

As illustrated, the main body 9022 (e.g., see FIG. 169-179) of the frame9020 includes an open construction with a central opening 9024 to allowthe sealing arrangement 9040 to communicate with or receive a side wall9026 structured to retain or otherwise engage the sealing arrangement9040. In use, the frame 9020 of this example is not in the air path,i.e., sealing arrangement 9040 defines breathing cavity and is directlycoupled to the inlet tube 9070 as described below. The frame 9020 may besemi-rigid or at least allow for some flexibility. The frame 9020 may bemade from a single material, a combination of materials, or acombination of the same material in varying hardnesses. The frame 9020may be made from polycarbonate, polypropylene, nylon, thermoplasticelastomer (TPE), silicone, or any other suitable material.

A forehead support 9030 extends from the top end of the main body 9022.The forehead support 9030 may be fixed (i.e., un-adjustable), adjustable(e.g., the height or length of elongated arm may be extendable, or theangle of the forehead support may be changeable), or interchangeable(e.g., various sizes of forehead supports for different sized patientsor the elongated arm may be replaced with different various lengths ofarm). The forehead support 9030 includes an elongated arm 9032 and anupper headgear connector 9034 providing slots or receiving holes 9035 atthe free end of the arm adapted to receive respective headgear straps inuse, thus using the padding of the headgear straps rather than requiringa separate pad. In an example, the headgear connector may be adjustable,e.g., ‘with respect to the arm 9032 (e.g., tilt or angle towards thepatient's forehead).

Lower headgear connectors 9036 are provided to respective sides of themain body 9022, each lower headgear connector 9036 including elongatedarms 9038 and a slot or receiving hole 9039 at the free end of the armadapted to receive a respective headgear strap in use. The elongated arm9038 may be bendable or selectively deformable so as to allow the arm tobend towards or away from the patient's face in use, thereby pulling theheadgear onto the patient's face, e.g., enabling side sleeping. Theforehead support and headgear connectors may provide a relativelyunobtrusive arrangement which minimizes the impact on the patient's lineof sight. Preferably, each elongated arm 9038 may include a deformablehook positioned on the end of the arm opposed to the connection of themask frame. The deformable and resilient hook may be constructed ofsilicone and may be selectively deformable to allow a strap of theheadgear to pass over the hook but wherein the hook resists or limitsthe strap from being pulled from the mask accidentally.

In an example, the arms 9032 may be suitably formed, shaped, orcontoured to follow the contours of the patient's face while avoidingthe patient's line of sight or impeding their vision. Also, the arms9032 may include some inherent flexibility to allow a range ofadjustment. The elongated arms 9032 may be made from a substantiallyinextensible material such as aluminum, stainless steel, polycarbonate,polypropylene, TPE, or any other suitable material. Alternatively, theelongated arms 9032 may be continuous with the frame 9020 and thereforemade from the same material, or the elongated arms 9032 may be made fromthe same material as the frame 9020 but not a single piece construction(i.e., the elongated arms 9032 may be attached to the frame 9020).However, wherein the elongated arm 9032 is made of different materialfrom the frame 9020, the elongated arm 9032 may be secured onto frame 20using an alternative fixing or securing method, e.g., such as gluing.The upper headgear connector 9034 may be made from the same material asthe elongated arm 9032. Alternatively, the upper headgear connector 9034may be made from a more flexible material than the elongated arm 9032such as Hytrel™, silicone, nylon, or other suitable materials orcombinations thereof. The lower headgear connectors 9036 may becontinuous with the frame 9020 and therefore made from the samematerial, or the lower headgear connectors 9036 may be made from thesame material as the frame 9020 but not a single piece construction.Alternatively, the lower headgear connectors 36 may be made from a moreflexible material than frame 9020 such as Hytrel™, silicone, nylon, orother suitable materials or combinations thereof.

The forehead support and headgear connectors may be integrally mouldedor otherwise attached to the main body of the frame 9020. The frame 9020is constructed from a more rigid material than the sealing arrangement9040 (e.g., made of silicone, foam). For example, the frame may beconstructed of plastic (e.g., polycarbonate), metal materials (e.g.,relatively thin metal material) or combinations thereof.

In an example, the arms 9032 may be relatively thin or slender (e.g.,1-3 mm). In an example, the forehead support 9030 and headgearconnectors 9036 may be formed of a material (e.g., metallic material)which is different than the material of the frame main body 9022. Insuch example, the forehead support 9030 and headgear connectors 9036 maybe attachable to the frame main body 9022. The relatively thin orslender arms 9032 may reduce the overall visual impact of the mask orembodiment.

In an example, upper headgear connector 9034 provides a flattened areafor the attachment of straps from the headgear. In an example, thestraps attach to the upper headgear connector 9034 through two apertures9035 mounted on opposed sides of the upper headgear connector 9034 andthe straps are adapted to extend through the apertures and elicit aforce towards the patient's face and effectively pull the upper headgearconnector 9034 towards the patient's forehead, in this embodiment.

1.1.10.6 Certain Embodiments of the Vent Arrangement

The cushion 9042 may include a vent arrangement for gas washout. Thevent arrangement includes a plurality of holes (e.g., 1-100 holes, e.g.,20-50 holes, or about 45 holes). Each hole may include a contour ortaper along its length. However, it should be appreciated that the ventarrangement may include other suitable arrangements, e.g., differentnumber of holes, hole arrangement, vent insert with one or more ventholes, etc.

The vent may also, for example, be a diffuse vent as disclosed in U.S.Patent Application Publication 2009/0050156 A1, which is incorporatedherein by reference in its entirety.

Various types of vents may be plugged into the vent arrangement 9075,and/or the vents are removable for cleaning.

1.1.10.7 Certain Embodiments of the Headgear

Headgear may be removably attached to the headgear connectors 9034, 9036of the frame 9020 to maintain the nasal mask system in a desiredposition on the patient's face. In the illustrated example, the frameprovides a four-point connection for a pair of upper headgear straps anda pair of lower headgear straps. However, the frame may provide otherarrangements, e.g., two-point connection or three-point connection.Rigidisers or reinforcing materials may be provided to one or more ofthe straps.

Headgear may be constructed of an elastic or flexible material such aswoven and non-woven fabric, TPE, polypropylene, nylon, or other suitablematerials or combinations thereof. The headgear may also be reinforcedwith stiffening members that may add stability.

The nasal mask system may be used with headgear such as that describedin Australian Provisional Application No. 2010900237, filed Jan. 22,2010, which is incorporated herein by reference in its entirety.

Attachment/adjustment of such headgear may be provided by buckles orhook and loop material. For example, the headgear straps may beconstructed of a nylon elastic material with strap adjustment providedby buckles without any hook and loop material. However, the nasal masksystem may be used with alternative headgear arrangements.

1.1.10.8 Certain Embodiments of the Forehead Support

The forehead support 9030 is supported by the arm 9032. As shown inFIGS. 169-179, the forehead support 9030 may have flexible region 9031built into the forehead support to allow it to spring from its naturalv-shaped position or shape to a more linear position or shape. Theflexible region may be a thinned portion of material (i.e., samematerial as rest of forehead support, but thinner to allow flex).

The flexible region may be a co-moulded portion of flexible material,such as thermoplastic elastomer (may also be colored). The remainder ofthe forehead support may be made from a less flexible material such aspolycarbonate or polypropylene. Co-moulding may be via a chemical ormechanical bond between the two materials. The separatelyformed/assembled TPE part reduces breakage risks and enables assemblyoffsite with the headgear. The forehead support may include a frostedfinish.

The flexible region provides an auto-adjust flex feature that isadjusted with headgear tension enabling greater biasing of the cushionto assist fit.

Alternatively, the forehead support may be made from a thickened,compliant material, such as foam, that can be compressed therebyachieving a similar result.

The position of the forehead support without any loading (i.e., naturalstate), may be demonstrated as angle a, e.g., angle a may be about5-90°, e.g., about 15°.

In use, the forehead support may allow about 15 mm of adjustment in theanterior-posterior direction. This may allow for a greater fit range ofpatients as it may accommodate a greater variety of anthropometrics,particularly at the nasal bridge region. In certain embodiments, theforehead support may allow for at least 10 mm, 12 mm, 15 mm, 16 mm, 18mm or 20 mm of adjustment in the anterior-posterior direction.

Headgear may attach to the forehead support through loop holes 9035 ormay attach through a loop through arrangement.

1.1.10.9 Certain Embodiments of the Tubing

Certain embodiments of the disclosure may be adapted to be connected tohead connected pressurized breathable gas flow generator for thetreatment of sleep apnea or respiratory conditions. The flow generatormay be adapted to be relatively light and not relatively bulky whencompared to traditional medical pressurized air flow generators. Theheadgear may be adapted to prevent or limit the transmission of noiseand vibration along its component strap(s). The patient interface may besecured to the patient's face by the attachment of headgear straps andthe flow generator may be also supported and secured by the headgear.The flow generator may deliver pressurized breath gas by a relativelyshort length of tubing 9100 (as shown in FIGS. 175-182), also referredto as an intermediate tube or connector tube.

This tubing 9100 includes a first 9104 and a second end 9103 connectedby circular or cylindrical cavity extending throughout the middle of thetubing 9100.

In certain embodiments, the tubing 9100 at the second end 9103 isadapted to slidably connect within the inlet tube 9074. The second end9103 include a small notch or shoulder 9105 to engage the top of theinlet tube 9074 and limit the extent to which tubing 9100 may beinserted into the inlet tube 9074.

The connector tube 9100 includes a D-shape, or substantially D shaped,cross section when the cross section is taken relative to the width ofthe tubing. This D-shape or rounded trapezoidal cross section, mayreduce the visual impact of the connector tube 9100. Additionally, itmay strengthen the connector tube 9100 and increase its resistance toaccidental occlusion during use. It should be appreciated that othercross sectional shapes may be used.

The side profile and lengthwise cross section (as shown in FIG. 182include a rounded or arcuate profile. This arcuate profile may beadapted to conform with the arc formed between forehead of the patient(which correlates with the top of the patient interface) and the crownor in front of the crown of the patient's head where the flow generatormay be secured.

The length of the connector tube 9100 between the patient interface andthe flow generator may be shorter than most similar lengths of tubingused for similar applications. Typically, the length of the connectortube is less than, for example, 30 cm but is sufficient to join thepatient interface with the flow generator mounted on or in front of thecrown of the patient's head. The short length of connector tube 9100also has the advantage of reducing the amount of dead space between thepatient interface and flow generator. This may lead to increases in thereliability of data acquired from sensors (e.g. pressure sensors in theflow generator).

The supplied PAP system may include several (e.g. 2-10) differentlengths of connector tube 9100, so as to allow adaptability of thesystem to different patient head types and lengths. The length of thetubing may range from 1-30 cm.

Additionally, the connector tube 9100 may include positioning holesadapted to receive a mating spigot from the flow generator. This mayensure the correct orientation of the connector tube 9100 and mayminimize vibration transmission from the flow generator.

The connector tube 9100 may be shaped or adapted to minimize noise orvibration transmission from the flow generator. The connector tube 9100may include various baffles in the air path (not shown) ornoise/vibration absorbing walls (not shown). Additionally, the lowerside 9106 is adapted to contact the upper forehead of the patient. Thelower side 9106 is flat, or substantially flat, and relatively wide whencompared to the circumference of the cavity 9102. This may increase thecontact area of the lower side 9106 with the patient and further reducevibration of the flow generator, tubing and patient interface. The noncircular shape of connector tube 9100 may reduce echoing of air passingthrough the tube and setup an interference pattern further reducing anddamping noise and/or vibration.

The connector tube 9100 may be constructed of flexible polymer material,wherein the material may be resilient enough to retain its shape duringuse and/or resist accidental occlusion. For example, the tubing 9100 maybe constructed of silicone. The connector tube 9100 may be softer andmore flexible than the portions that it connects to. For example, theintermediate tubing 9100 is softer and more flexible than the housing orthe outlet of the flow generator; and also the connection point to thepatient interface. T, this may be achieved by including a lowerdurometer material for constructing the connector tube 9100.Additionally, the softer and flexible connector tube 9100 may alsoadditionally dampen noise and/or vibration transmission from the flowgenerator to the patient interface.

The connector tube 9100 shown in FIG. 182 includes end portions whichare relatively straight, however, other suitable configurations may beused. The first end 9104 may include a straight end of 10 mm and thesecond end 9103 may include a straight end of 15 mm. The two ends may bejoined by a natural arc between them.

The length of the connector tube 9100 as measured along the midlinechord between the first and second ends may be for example, about 116mm. Other chord lengths may be used, for example, 80 mm and 150 mm tocorrespond to small and large sizes of tubing.

The sealing arrangement 9040 may be constructed of a soft and flexiblematerial and co-moulded with the inlet tube 9070. Here, the cushion 9040forms a mask that is retained and secured in position by the resilientand deformable frame 9020. T, the frame may clip onto the sealingarrangement by attaching the outer surface of the cushion 9040 and thebridge 9038 joining to the inlet tube 9070.

Referring to FIGS. 183-192, a headworn PAP system according certainembodiments comprises a PAP device 8000 that includes a blower or flowgenerator. Referring to FIG. 184, the PAP device 8000 is supported on anextension 8003 of a headgear 8010 and is secured between two raisedportions 81 SO that extend from the extension 8003 of the headgear.Upper headgear straps 8002 are connected to upper headgear connectors9034 of a frame 9020 of a patient interface system that supports apatient interface device, or cushion, 9042 in sealing engagement withthe face of the patient. The upper headgear straps 8002 are connected tothe headgear by fasteners 8004.

Lower headgear straps 8005 are connected to the frame 9020 by headgearconnector clips 8007 that attach to the frame 9020 in a manner describedin more detail below. As shown in FIG. 184, the lower headgear straps8005 are connected to the occipital ring 8001 of the headgear at theback of the patient's head by fasteners 8004. The fasteners 8004 for theupper headgear straps 8002 and the lower headgear straps 8005 may be,for example, hook and loop fasteners, such as Velcro™.

Lower headgear straps 8005 are connected to the frame 9020 by headgearconnector clips 8007 that attach to the frame 9020 in a manner describedin more detail below. As shown in FIG. 184, the lower headgear straps8005 are connected to the occipital ring 8001 of the headgear at theback of the patient's head by fasteners 8004. The fasteners 8004 for theupper headgear straps 8002 and the lower headgear straps 8005 may be,for example, hook and loop fasteners, such as Velcro™.

The patient interface system, which may be, for example, a nasal masksystem or a full face mask system comprises the frame 9020 whichsupports the sealing arrangement 9040. The sealing arrangement 9040comprises the cushion 9042 which is configured to sealingly engage theface of the patient. As shown in FIG. 183, the cushion 9042 includeselongated, spaced apart protrusions 9050 that engage the frame 9020 tosecure the sealing arrangement, including the cushion 9042, to the frame9020. As further shown in FIG. 183, the frame 9020 comprises a foreheadsupport 9030 which supports the upper headgear connectors 9034. As shownin FIG. 184, the forehead support 9030 of the frame 9020 engages andholds the inlet tube 9070 of the sealing arrangement 9040. A shortoutlet tube 9100 is connected to the PAP device 8000 and delivers theflow of pressurized breathable gas from the PAP device 8000 to the inlettube 9070 of the sealing arrangement 9040. The short outlet tube 9100may comprise ribs 9150 which provide flexibility to the short outlettube 9100 to accommodate patients with different facial shapes andsizes.

Referring to FIG. 185, the sealing arrangement 9040 comprises thecushion 9042 including the spaced apart, elongated protrusions 9050 thatconnect the sealing arrangement 9040 to the frame 9020 by engagingsidewalls 9026 (FIG. 190) of the frame 9020. The cushion 9042 mayinclude an opening 9075 which receives a vent structure for ventingexhaled gases.

The inlet tube 9070 of the sealing arrangement 9040 includes a first end9072 adjacent the cushion 9042 and a second end 9074 that receives theflow of pressurized breathable gas from the PAP device 8000. The inlettube 9070 includes a reduced diameter portion 9071 that is inserted intothe short outlet tube 9100 that is connected to the PAP device 8000.

As shown in FIG. 186, the headgear 8010 includes the extension 8003 tosupport the PAP device 8000 between the raised portions 8150. A securingstrap 8030 is provided on the extension 8003 of the headgear 8010 tosecure the PAP device 8000 to the extension 8003 of the headgear 8010.

Referring to FIGS. 187 and 188, the frame 9020 of the patient interfacesystem includes lower headgear connectors 9036 that receive the lowerheadgear clips 8007 of the headgear 8010 to secure the lower headgearstraps 8005 to the frame 9020.

As also shown in FIGS. 187 and 188, the inlet tube 9070 of the sealingarrangement 9040 may be fully inserted into the short outlet tube 9100,as shown in FIG. 187, and the inlet tube 9070 may be extended from theshort outlet tube 9109 as shown in FIG. 188 to accommodate patients witha larger head size.

Referring to FIGS. 189A to 189H, the short outlet tube 9100 has a firstend 9104 configured to be connected to the outlet of the PAP device 8000and a second end 9103 configured to receive the inlet tube 9070 of thesealing arrangement 9040. The lower side 9106 (i.e. the side facing theforehead of the patient) of the short outlet tube 9100 may comprise aplurality of ribs 9150 that increase the flexibility of the short outlettube 9100. As shown in FIGS. 189A to 189H, the short outlet tube 9100may be D-shaped in cross section and the lower side 9106 may besubstantially flat when compared to the circumference of the cavity9102. However, it should be appreciated that other cross-sectionalshapes for the short outlet tube 9100 may be utilized.

Referring to FIGS. 190-192, the frame 9020 of the patient interfacesystem comprises a main body 9022 that includes a pair of arms 9032 thatsupports the forehead support 9030. The forehead support 9030 maycomprise an arcuate bridge 9038 that is configured to resiliently engagethe inlet tube 9070 of the sealing arrangement 9040 to secure the inlettube 9070 to the frame 9020. A central opening 9024 provided in theframe 9020 is configured to receive the cushion 9042 of the sealingarrangement 9040. The main body 9022 further comprises side walls 9026that are configured to engage the protrusions 9050 of the cushion 9042to secure the cushion 9042 to the frame 9020. The frame 9020 furthercomprises lower headgear connectors 9036 that are configured to beengaged by the lower headgear clips 8007 of the headgear 8010 to securethe lower headgear straps 8002 to the frame 9020. As shown in FIG. 191,the lower headgear clip 8007 may comprise a hook 807 5 configured toengage the lower headgear connector 9036 of the frame 9020. A releasetab. 8077 may be provided on the lower headgear clip 8007 to allow thepatient's finger to engage the lower headgear clip 8007 and disengagethe hook 8075 from the lower headgear connectors 9036.

Referring to FIGS. 193A to 195B, a patient interface system according toanother embodiment is shown. A connector tube 9200 is provided toconnect the sealing arrangement 9040 to the short outlet tube 9100 thatis connected to the PAP device 8000. The connector tube 9200 includes afirst end 9201 that is configured to be inserted into the inlet tube9070 of the sealing arrangement 9040 and a second end 9203 that isconfigured to be inserted into the short outlet tube 9100. The first end9201 includes a. rib 9205 that may engage a first groove 9073 or asecond groove 9075 in the inlet tube 9070, as shown for example in FIG.195B. Although the engagement of the connector tube 9200 to the inlettube 9070 of the sealing arrangement 9040 is shown as a rib beingreceived in a groove, it should be appreciated that other connectionstructures for attaching the connector tube 9200 to the sealingarrangement 9040 may be used, for example, a screw connection.

The connector tube 9200 includes a circumferential flange 9211 thatdefines a maximum insertion position of the connector tube 9200 into theinlet tube 9070 of the sealing arrangement 9040, as shown in FIG. 194B.The second end 9203 of the connector tube 9200 includes a first rib 9207and a second rib 9209 that are configured to engage a groove or groovesformed on the inner circumference of the short outlet tube 9100. Theconnector tube 9200 is inserted, retained and sealed in the inlet tube9070 of the sealing arrangement 9040 by the rib 9205 and fits via aninterference fit in the inlet tube 9070. The connector tube 9200 isfully inserted into the inlet tube 9070 as shown in FIGS. 194A and 194B,and may be extended from the inlet tube 9070 as shown in FIGS. 195A to195B to accommodate patients having different head sizes.

Referring to FIGS. 196A to 197C, a connector tube 9200 according tocertain embodiments includes a first end 9201 configured to be insertedinto the inlet tube 9070 of the sealing arrangement 9040 and a secondend 9203 configured to be inserted into the short outlet tube 9100connected to the PAP device 8000. A circumferential flange, includingtwo tabs 9219 is provided between the first end 9201 and the second end9203. A first rib 9221 and a second rib 9223 may be provided to retainthe tube connector 9200 in the inlet tube 9070 of the sealingarrangement 9040, and a first rib 9225 and a second rib 9227 may beprovided to retain the second end 9203 of the connector tube 9200 to theshort outlet tube 9100.

As shown in FIGS. 197A and 197B, the tabs 9219 of the connector tube9200 may be received in slots 9021 formed in a forehead support 9030 ofthe frame 9020. The locking of the tabs 9219 into the slots 9021maintains the axial alignment of the connector tube 9200 with the inlettube 9070 of the sealing arrangement 9040 and the short outlet tube9100. The tabs 9219 snap into the slots 9021 of the frame 9020 frombehind and the frame momentarily flexes outwardly while the tabs 9219push in, and the frame then pops back into position when the tabs arereceived in the slots 9021.

The connector tube 9200 may be manufactured in a range of differentsizes to suit different size faces. The user may select theappropriately sized connector tube and connect the connector tube to theshort outlet tube 9100 and the inlet tube 9070 of the sealingarrangement 9040.

Referring to FIGS. 198A to 202D, a patient interface system according toanother sample embodiment is shown. The patient interface systemincludes a connector tube 9200 having a first end 9201 configured to beattached to a short outlet tube 9100 that is configured to be connectedto the PAP device. As shown in FIG. 200D, the first end 9201 of theconnector tube 9200 is configured to be inserted into a second end 9103of the short outlet tube 9100.

The connector tube 9200 includes a second end 9203 that is configured tobe attached to the inlet tube 9070 of the sealing arrangement 9040. Asshown in FIG. 198D, the connector tube 9200 includes a first rib 9207and a second rib 9209 that are configured to engage the interior of theinlet tube 9070 of the sealing arrangement 9040, for example via aninterference fit, to secure the connector tube 9200 to the inlet tube9070 of the sealing arrangement 9040. The connector tube 9200 alsoincludes a flange 9217 extending around the circumference of theconnector tube 9200 to contact the second end 9103 of the short outlettube 9100 when the connector tube 9200 is fully inserted into the shortoutlet tube 9100, as shown in FIG. 202-4.

As shown in FIGS. 198A and 198D, the connector tube 9200 may includeposition indicators 9215, which may take the form of grooves or bumps,provided on an outer surface of the connector tube 9200 to indicate theextent to which the connector tube 9200 is inserted into the shortoutlet tube 9100, for example, as shown in FIGS. 201A and 201C.

The flange 9217 of the connector tube 9200 may engage slots in theframe, for example, the slots 9021 shown in FIG. 197A. In addition, theconnector tube 9200 may also include a tab 9219 that is configured to beinserted into a slot 9023 formed in the forehead support 9030 of theframe 9020, as also shown in FIG. 197A.

As shown in FIGS. 198A to 202D, the connector tube 9200 telescopeswithin the short outlet tube 9100 to allow adjustment of the length ofthe air delivery tube to the patient interface to adjust for differentsize foreheads. In a sample embodiment, the position indicators 9215 ofthe connector tube 9200 may provide a tactile feedback of the positionof the connector tube 9200. It should also be appreciated that theposition indicators 9215 may not be used and friction may be used as anindicator of the position of the connector tube 9200. It should furtherbe appreciated that a locking mechanism may be provided to lock in theadjusted height of the connector tube 9200 with respect to the shortoutlet tube 9100.

The connector tube 9200 is inserted, retained and sealed in the inlettube 9070 of the sealing arrangement 9040 by the ribs 9207, 9209. Thefirst end 9201 of the connector tube 9200 has a rib 9231 (FIG. 198C)that provides an interference fit with the interior of the short outlettube 9100 as shown, for example, in FIG. 201D. The cavity 9102 of theshort outlet tube 9100 includes an interior rib 9131 that is configuredto engage the position indicators 9215 of the connector tube 9200 toretain the connector tube 9200 in a selected position relative to theshort outlet tube 9100, as shown, for example, in FIG. 201D.

Although the connector tube 9200 has been described as including tworibs 9207, 9209, it should be appreciated that more than two ribs andmore than two grooves in the inlet tube 9070 of the sealing arrangement9040 may be used. It should also be appreciated that one rib and onegroove may be used. The connector tube may be made from a resilientmaterial, for example, silicone. It should be appreciated that othermeans of attaching the connector tube 9200 to the inlet tube 9070 of thesealing arrangement 9040 may be used, for example, a screw-inconnection.

According to certain embodiments, the headworn PAP system may beconfigured to fit a percentage of the patient population, for exampleabout 70-90%, such as 80%. The headworn PAP system may fit a headcircumference of, for example, about 540-620 mm, and a forehead heightof about 70-110 mm. In certain embodiments, the connector tube 9200 mayallow a fit range of about 30-60 mm for the forehead tube, whichprovides an adjustment range of about 30 mm.

Referring to FIGS. 203A to 203E, a short outlet tube 9100 in accordancewith another sample embodiment is illustrated. To provide furtherflexibility and adjustment around the patient's face, a bellows section9115 is provided in the short outlet tube 9100, for example at the areawhere the short outlet tube 9100 bends (i.e. at the knuckle). Thebellows section 9115 allows the tube to flex more easily.

1.2 Certain Embodiments of the Blower Built into the Mask

Certain embodiments relate to PAP systems in which the blower may bebuilt into or incorporated into the patient interface and/or mask. Incertain embodiments, the blower may be divided into two or more smallerblowers. Miniature blowers, such as the small 8 W blowers manufacturedby Maxar having a diameter of 8 mm and a length of approximately 30 mm,may be utilized, or other commercially available blowers.

FIGS. 4 to 9C and 24-35 show masks with a built in blower according tocertain embodiments.

In FIG. 4, the patient interface or mask system 10 includes a nasalprong or pillow arrangement 330 adapted to form a seal with thepatient's nares. First and second blowers 350(1), 350(2) are provided torespective ends of the nasal prong arrangement to provide pressurizedair to the nasal prong arrangement. The mask may be attached to thepatient's face by a combination of hook and loop (e.g., Velcro) tabs andadhesive.

In certain embodiments, one blower may be used. In certain embodiments,at least one, two, three or four blowers may be used.

Blowers 350(1) and 350(2) may be encapsulated by a damping means. Forexample, damping means may include a muffler, such as a silicone casing,a foam and/or fabric layer, other suitable materials or combinationsthereof.

Tab portions 353 may be connected to the nasal prong arrangement 330 forremovably attaching it to an adhesive facial pad 332. Tab ‘portions mayinclude integrally moulded hooks to engage with loops provided on theadhesive facial pad. In an embodiment, attachment means may be providedas disclosed in pending U.S. Patent Application Publication 2010/0000534A1.

Muffling and/or filtering materials may be provided to the air inletportions of the blowers 350(1) and 350(2). For example, foam pads may beattached or otherwise formed with blowers at their inlet portion.

In FIGS. 5A and 5B, the patient interface or mask may include a nasalprong or pillow arrangement 430 adapted to form a seal with thepatient's nares. First and second blowers 450(1), 450(2) are providedin-line with respective nasal prongs to provide pressurized air.

Nasal prongs may be provided with barbs or interference means to engagewith an inner portion of a patient's nares.

The blower may be positioned such that the outlet directs airflowdirectly into a nasal prong, and the inlet receives air through anaperture in the cushion. The inlet may be adjacent or near a filterand/or muffler 451 so as to reduce noise and provide the patient withclean air. The filter and/or muffler may comprise a filter material,foam, fabric, mesh, other suitable materials or combinations thereof.

Headgear straps 452 may be connected to a cushion for securing thepatient interface to the patient. The headgear straps may be connectedat the rear of the patient's head by a slidably engaging portion 453.The headgear straps may connect to the blowers and comprise wiring tosupply power to the blowers. Power is provided to the blower via a wireto a control unit that includes a power supply unit. The control unitmay also comprise a user interface to allow the setting of parameters tocontrol the blowers.

In FIGS. 6A and 6B, the patient interface includes a nasal cushion 530and first and second blowers 550(1), 550(2) provided to respective endsof the nasal cushion to provide pressurized air to the nasal cushion.The silicone cushion provides ducting to communicate pressurized airfrom the blowers to the nasal cushion.

In certain embodiments the first and second blowers 550(1), 550(2) maybe directed to different nostrils and operate independently of oneanother. Each blower providing pressure support and flow to a differentnostril. It is believed that at least some patients may breathe throughone nostril at a time and rest the other nostril, with the breathing andnonbreathing nostrils changing periodically. The blowers may be adaptedto detect from which nostril the patient is breathing and co-ordinatethe supply of pressure from the first or second blower according towhich nostril they are associated with. Alternatively the blowers may beconfigured to turn on and off the supply of pressure and flow to thedifferent nostrils periodically according to a predetermined timepattern. The two blowers may each be on a timer and a communicationsystem may control the operation of the two blowers. It is noted thatsuch a two blower system may also be used with nasal pillows or pronginterface system.

The cushion may be a thermoformed textile, e.g. see FIG. 6B includingfabric portion 530(1) and silicone sealing portion and ducts 530(2). Thetextile could be woven or nonwoven. The cushion may include a foamand/or fabric layer. The thermoformed textile may include a sealingsurface, such that is non-air permeable or at least minimally permeable.This may be achieved by silicone spraying, moulding or otherwiseattaching a non-permeable or minimally permeable material to one or moreportions of the fabric. Alternatively, the cushioning portion may beremovably attached to the sealing surface. The sealing surface mayinclude a patient contacting portion, a frame or support portion formaintaining the cushion away from the user's nose, and a ducted portionfor attaching to air delivery tubes.

Headgear straps 540 may be formed by ultrasonic welding and/orthermoforming. Headgear straps may be made from a fabric and foamcomposite. Headgear straps may alternatively be a fabric. Headgearstraps may include reinforcing portions. Headgear straps may furtherinclude additional baffling or muffling portions 541 to reduce noisefrom the blower and/or cushion. For example, muffling portions are shownin FIG. 6A positioned near or proximal to the patient's ears, to preventexcessive noise travelling to the patient's ears.

In FIGS. 7A and 7B, the patient interface includes a frame 620, a nasalcushion 630 provided to the frame, and a blower 650 provided to thefront of the frame and communicated with the breathing chamber definedby the cushion. In certain embodiments, the headgear and/or patientinterface may include one or more aspects as described in WO 2009/052560A1 and U.S. Patent Application Publication 2009/0044808 A1, U.S. Pat.No. 7,318,437, or International Application PCT/AU2009/000241, filedFeb. 27, 2009, each of which is incorporated herein by reference in itsentirety.

Headgear 640 shown in FIGS. 7A and 7B may include a cable or wiringsystem that is moulded into the headgear strap. For example, the wiring640(1) may be encapsulated within a foam and/or fabric strap 640(2) asshown in FIG. 7B, wherein the foam and/or fabric may be formed bythermoforming and/or ultrasonic welding. The foam may be used to supportthe wires in position, insulate the cables and maintain the wires in anunobtrusive manner. The wiring is shown in the form of a ribbon cable,although other forms of wiring may be utilized.

In FIGS. 8A and 8B, the patient interface includes a frame 720(including a forehead support), a full-face cushion 730 provided to theframe, and a blower 750 provided to the front of the frame andcommunicated with the breathing chamber defined by the cushion. A meshvent 751 is mounted on either side of the blower. The mesh vent wouldallow air to flow into the blower as indicated by the arrows in FIG. 8B.The mesh vent acts as a first filter for the incoming air.

The frame 720 includes an aperture or ring for engaging with a blower750. The blower may clip or otherwise engage with the frame.

A second filter 752, such as a HEPA filter, may be fitted to an innerportion of the mask near or proximal to the outlet of the blower tofilter the air being delivered to or expired from the patient. It mayalso assist in damping the noise.

In FIGS. 9A to 9C, the patient interface includes a nasal cushion 830,headgear 840 to support the cushion in position on the patient's head,and a blower 850 supported by the headgear. The nasal cushion 830 may beconstructed of a compliant material such as silicone, gel, or foam. Theblower may be overmoulded or otherwise encapsulated in a housing, wherethe housing may be made from a plastic, metal, or other material that isable to maintain its shape. The housing may also function as a mufflerto reduce noise. In certain embodiments, the cushion may include one ormore aspects as described in Australian Application 2009902524, filedJun. 2, 2009, which is incorporated herein by reference in its entirety.

Headgear 840 for supporting the mask 830 may include a channel or otherattachment means for a power supply cable to connect the motor to apower supply. The channel may be contained within the headgear. Thechannel may protect the wiring, prevent entanglement or strangulation ofthe patient and give the system a streamlined appearance. The headgear840 may be thermoformed or otherwise shaped.

A muffler or filter may also be fitted over an inlet 852 of the bloweradjacent the mask 830. The muffler or filter may be a foam or fabricmoulded or attached to the headgear, as shown in FIG. 9B. Alternatively,the muffler or filter may be a non-woven material. The muffler or filtermay filter exhaled gases and/or reduce the noise from the mask andblower. In a further alternative, the muffler or filter may beintegrally formed or apart of the headgear. As shown in FIGS. 9B and 9C,the outlet 853 of the blower may be connected to the cushion 830 throughthe headgear 840 by a motor cuff 854 of the blower.

FIGS. 24-35 show alternative frame configurations for attachingheadgear, alternative headgear arrangements, alternative cushion orsealing arrangements, and/or alternative blower configurations. Forexample, in FIGS. 24 and 25, the patient interface 10 includes a blower50 supported by the mask frame. As shown in FIG. 25, the blower mayinclude a symmetrical housing that provides an aesthetically pleasingdevice. The housing includes an inlet 52 for the blower provided in afirst half, and a muffler or filter 66 provided in a second half. InFIG. 26, a mask 10 wherein the blower is built into the mask is shown.The mask includes a frame 16 that supports a cushion 17 formed of, forexample, silicone that includes a seal 15 to sealingly engage thepatient's face. A blower 50 is mounted on the mask. An inlet filterand/or muffler 18 may be provided to filter the air and/or reduce theoperating noise of the blower 50. In certain preferred embodiments, themask 10 may be provided for ventilation, i.e. no venting of the mask maybe provided. In FIGS. 27A and 27B, snap on pillows or nasal prongs 60may be provided to the blower 50. In FIGS. 28 and 29, the patientinterface 10 may provide a foam intake. In FIGS. 30-35, the blower isprovided to the front of the mask and the mask includes a streamlineddesign.

For example, FIG. 24 shows a pair of blowers or blower housings mountedon to the mask or patient interface. The inlets of the blowers arepositioned horizontally outwards in the medial-lateral direction. Asimilar configuration is demonstrated in FIG. 25.

FIGS. 27A and 27B depicts a blower outlet being connected directly to apatient interface. The patient interface shown is a pillows or prongarrangement. Alternative patient interfaces may be used, for examplenasal cradles, nasal, full face or oro-nasal masks.

1.3 Certain Embodiments Relating to Portable

Certain embodiments of the present disclosure relate to portableblowers.

FIGS. 10-11, 36-39, and 45-48 show portable blowers according certainembodiments of the present technology.

As shown in FIG. 10, the portable blower 950 may be adapted to bemounted by the patient's bedside or wall. The bedside embodiment mayinclude a detachable blower mounted on a docking station 970 ornightstand. The detachable blower may include batteries, such as lithiumion batteries, for powering the device when not connected to the main/ACpower. The night stand may be fitted with an overhead tube 960 (flexibletube, fixed shape tube, or combination thereof) adapted to connect totubing associated with the mask. The overhead tube may be made from ametal such as stainless steel, or polymer such as thermoplastics orsilicone, or combination thereof. The overhead tube may be able torotate on the stand or bend in selected regions such as the tophorizontal bar. The overhead tube includes a series of lights or LED'sat the cuff or connection region with the mask tube which can beactivated by touch or by a change in the system (such as detachment).Also the overhead tube can provide a soft light for the patient to seeat night. The light may assist the patient when detaching or reattachinga flexible mask tube to the overhead tube. The color of the light may beassociated with an activation reason. The cuff or connection region ofthe overhead tube may include a magnet that may attract a magnet orferrous material at the end or connection region of the mask tube. Thismay aid attachment of the mask tube to the overhead tube.

In FIG. 11, the blower is adapted to be mounted to the wall or bedhead.An overhead tube 1060 may extend from the blower and adapted to connectto tubing associated with the mask. A muffler and/or filter may beattached to the blower to filter gases being delivered to the patientand/or reduce the noise of the system. Similar to the embodiment in FIG.10, the overhead tube may be attached to the bed, bed head, wall or anyother region proximal to the patient. The overhead tube may connect to acase 1050, where the case 1050 receives a power supply for the blowersystem. The power supply may be a battery or mains power supply. Thecase 1050 may be constructed of a polymer such as thermoplasticelastomer, thermoplastic urethane, or may be constructed from a metalsuch as aluminum. The case 1050 may have a wire or other means ofcarrying the power supply to the blower attached to the end of theoverhead tube. The case may also include a microprocessor and userinterface to allow the control and setting of parameters for the blower.

In FIGS. 36 and 47, the portable blower 2650 may be attachable to ablower dock 2655 which may be structured to retain, charge, and/ordownload diagnostics from the blower.

In FIGS. 37A and 37B, the blower 2655 is in the form of a blower pouch.The pouch may be deflatable when not in use for portability.

In FIGS. 38A to 38D, the portable blower 2650 may be provided to a base2656 adapted to charge the blower by induction charging.

FIG. 39 shows embodiments of an overhead support 2657. A blower 2670 maybe supported by the support 2657 and supply a flow of breathable gas toa patient 2679 by a tub 2678, which may include light-up tubing.

FIGS. 45, 46, 48 and 49 show alternative casings 2658 for enclosing orprotecting a portable blower. For example, FIG. 45 shows a fabric orfoam/fabric type case, FIG. 46 shows a silicone type case, and FIGS. 48and 49 show an aluminum alloy type case. A foam or non-woven baffle orfilter 2659 snaps in and out of the case 2658.

A battery pack may be provided with the mask and blower system. Thebattery pack may be worn on the body of the patient. Alternatively, thebattery may be provided with a chord such that it may be positioned awayfrom the patient, for example on a bed side table. The battery may beflexible such that if it is worn on the body of the patient it may bendand conform to the general shape of the patient. The battery may have awire or cable connecting it to the motor. The cable may have a quickrelease or force release portion, such that if a force is applied to thecable, the cable will disconnect the battery from the motor. This may bebeneficial to avoid strangulation of the patient, or quick removal ofthe power from the motor.

1.4 Certain Embodiments Relating to Wearable

Certain embodiments relate to blowers adapted to be wearable and/orcarried by the patient and not mask or head mounted. In certainembodiments, the blower or blowers may be carried, wearable, positionedon the head, positioned on or adjacent the mask or combinations thereof.

FIGS. 40A to 44 and 50-52 show wearable blowers according to certainembodiments.

In FIGS. 40A and 40B, the blower 1150 is supported by a shoulder-typeharness 1180 which supports the blower adjacent the patient's chest.

In FIG. 41A, the blower 50 is supported by a pendant-type arrangement64. The pendant 64 may be part of a necklace, or pinned to the patient'sclothing. The blower 64 includes an air tube connector 63 for connectinga tube to deliver the flow of breathable gas. FIG. 41B shows a blower 50provided in a container configured to have a shape similar to a colognebottle.

In FIGS. 42A, 43 and 52, the blower 2150 is supported by an article ofclothing, such as a shirt (e.g., T-shirt) including a blower supportstructure (e.g., pocket) along the front of the shirt.

In FIG. 44, the blower 2150 is supported by a shirt (e.g., T-shirt)including a blower support structure (e.g., pocket) along the shoulderof the shirt.

FIGS. 50 and 51 show blowers 2150 supported by a strap or bandarrangement 2160. In FIG. 50, the strap wraps around the patient's neck,e.g., collar style. In FIG. 51 the strap wraps around the patient's arm.

In the following, further embodiments are explained with the help ofsubsequent examples.

The invention claimed is:
 1. A respiratory system configured topressurize and deliver a flow of respiratory gas to a patient's airways,the respiratory system comprising: a cushion configured to sealinglyengage the patient's face, the cushion forming at least part of a plenumchamber; a blower mounted to and supported by the plenum chamber andconfigured to pressurize the flow of respiratory gas; an interfacestructure that is attached to an outlet of the blower and an aperture inthe plenum chamber, the interface structure forming a gas flow pathbetween the plenum chamber and the blower, the gas flow path beingconfigured to deliver the pressurized respiratory gas from the blowerthrough the aperture in the plenum chamber and being configured to ventexhaled gas from the aperture in the plenum chamber to atmosphere; andheadgear configured to support the plenum chamber and the blower on thepatient's face, wherein the gas vented from the aperture in the plenumchamber is discharged through the headgear.
 2. The respiratory system ofclaim 1, wherein the blower is encapsulated within a housing configuredto mitigate the transmission of noise generated by the blower.
 3. Therespiratory system of claim 2, wherein the housing is overmoulded ontothe blower.
 4. The respiratory system of claim 1, wherein the cushion isa nasal cushion configured to sealingly engage the patient's nose. 5.The respiratory system of claim 1, wherein the headgear comprises anenclosed channel configured to receive wiring from the blower.
 6. Therespiratory system of claim 1, further comprising a muffler fitted overan inlet of the blower and attached to the headgear.
 7. A respiratorysystem configured to pressurize and deliver a flow of respiratory gas toa patient's airways, the respiratory system comprising: a cushionconfigured to sealingly engage the patient's face, the cushion formingat least part of a plenum chamber, a superior side of the plenum chambercomprising an aperture; a blower mounted to the plenum chamber andconfigured to pressurize a flow of respiratory gas, the blowercomprising an air outlet inserted into the aperture of the plenumchamber, the aperture of the plenum chamber and the air outlet of theblower forming a gas flow path configured to deliver pressurizedrespiratory gas from the blower to the plenum chamber and configured tovent exhaled gas from the plenum chamber to atmosphere; and headgearconfigured to support the plenum chamber and the blower on the patient'sface, wherein the blower is configured to receive the respiratory gasthrough the headgear, pressurize the respiratory gas, and then dischargethe pressurized flow of respiratory gas through the gas flow path. 8.The respiratory system of claim 7, wherein the blower is encapsulatedwithin a housing configured to mitigate the transmission of noisegenerated by the blower.
 9. The respiratory system of claim 8, whereinthe housing is overmoulded onto the blower.
 10. The respiratory systemof claim 7, wherein the cushion is a nasal cushion configured tosealingly engage the patient's nose.
 11. The respiratory system of claim7, wherein the headgear comprises an enclosed channel configured toreceive wiring from the blower.
 12. The respiratory system of claim 7,further comprising a filter fitted over an inlet of the blower andattached to the headgear.
 13. The respiratory system of claim 7, whereinthe blower is connected to the plenum chamber through the headgear. 14.A respiratory system configured to pressurize and deliver a flow ofrespiratory gas to a patient's airways, the respiratory systemcomprising: a cushion configured to sealingly engage the patient's face,the cushion forming at least part of a plenum chamber; a blower mountedto the plenum chamber and configured to pressurize a flow of respiratorygas; a common gas flow path connecting the plenum chamber to the blower,the common gas flow path being configured to deliver the pressurizedflow of respiratory gas from the blower to an aperture in the plenumchamber, the common gas flow path being configured to vent exhaled gasfrom the aperture in the plenum chamber to atmosphere; and headgearconfigured to support the plenum chamber and the blower on the patient'sface, wherein the exhaled gas vented from the aperture in the plenumchamber is vented through the headgear.
 15. The respiratory system ofclaim 14, wherein the blower is encapsulated within a housing configuredto mitigate the transmission of noise generated by the blower.
 16. Therespiratory system of claim 15, wherein the housing is overmoulded ontothe blower.
 17. The respiratory system of claim 14, wherein the cushionis a nasal cushion configured to sealingly engage the patient's nose.18. The respiratory system of claim 14, wherein the headgear comprisesan enclosed channel configured to receive wiring from the blower. 19.The respiratory system of claim 14, further comprising a muffler fittedover an inlet of the blower and attached to the headgear.
 20. Therespiratory system of claim 14, wherein the blower is connected to theplenum chamber through the headgear.
 21. The respiratory system of claim14, wherein the headgear comprises an aperture configured to fit aroundthe common gas flow path.
 22. The respiratory system of claim 14,wherein the headgear comprises a central portion configured to bepositioned between the blower and the plenum chamber at the common gasflow path.